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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004591-17 | EudraCT Number |
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Patients with microbiota alterations developed after being exposed to antibiotics are especially susceptible to Clostridioides difficile infections (CDI). The incidence and severity of CDI has increased in recent years and CDI recurrences (r-CDI) due to the appearance of new episodes in patients with a previous cured CDI, represent a serious and complex clinical issue. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure. In addition, the treatment of r-CDI is not adequately standardized, and although the most widely used treatment is the administration of fidaxomicin and bezlotoxumab, its efficacy in patients who already have r-CDI is not proven. In the late years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection.
The objective of this study is to assess the efficacy and safety of the MBK-01 medication, consisting of heterologous lyophilized fecal microbiota capsules coming from healthy donors in comparison to the treatment with fidaxomicin, in 92 patients with primary or r-CDI.
This is a Phase III, multicenter, controlled and open label clinical trial in which patients who suffered an episode of Clostridioides difficile infection (either the first episode or subsequent recurrences) will be randomly assigned (1:1) to one of the following arms:
Objective: To assess the efficacy of FMT with capsules of lyophilized fecal microbiota (MBK-01), compared to the control (fidaxomicin) at 8 weeks after the start of the treatment. Also, assess the safety of MBK-01 and the quality of life of patients participating in the study.
Follow up: participants will return for clinic visits at 72 hours, week 3 and week 8 after the start of the treatment, and will receive follow-up phone calls at month 3 and month 6 after the start of the treatment. Stool samples will be collected from participants for further studies at time 0 and week 8 after the start of the treatment. Study Outcomes are detailed in the specific section of this website.
Rationale: The transferred microbiota restores the recipient's intestinal microbiota by reintroducing bacterial taxa that were absent or in low proportion in the recipient before the FMT. This supports the expansion of the recipient's own commensal microbiota and re-establishing a microbiota community with a high biodiversity.
Donors: All donors are screened to ensure they meet the strict requirements necessary to maintain the safety of the MBK-01.
Justification: The treatment of Clostridioides difficile infections (CDI) with antibiotics is usually effective for acute symptoms, but after the initial treatment, the probability of recurrence at 8 weeks ranges from 10-20 % of cases, and once a patient has a recurrence, the probability of further recurrences increases up to 40-65 %. In recent years, Fecal Microbiota Transfer (FMT) has emerged as the preferred non-pharmacological treatment to manage CDI with multiple recurrences and recent clinical trials have evaluated its potential efficacy and safety in the treatment of patients with primary CD infection. Although antibiotics are the recommended therapy for the first episode of CDI, treatment with oral vancomycin and/or metronidazole often results in significant treatment failure, with recurrences occurring in up to 30-40% of patients. Furthermore, antibiotic treatment does not correct deficiencies in the intestinal microbiota that facilitate CD infection and is associated with the risk of the emergence of antibiotic-resistant bacteria. Moreover, the treatment of recurrences is not adequately standardized. In recent years, although the most widely used alternatives have been fidaxomicin and bezlotoxumab, their efficacy in patients who already suffer from r-CDI is not proven. The administration of the FMT through oral capsules, although it is not standardized, has proven to be effective in the restoration of intestinal microbiota of patients with r-CDI. In addition, the use of lyophilized formulas facilitates the concentration of bacteria and further optimizes the donors' sample and reduces the amount of capsules that the patient has to ingest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBK-01 | Experimental | Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients). |
|
| Fidaxomicin | Active Comparator | Participants will receive Fidaxomicin (47 patients). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBK-01 | Biological | A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment | Number of patients who showed recurrence of at least one Episode of Diarrhea (3 or More Stools/24 Hours) 8 Weeks After the Start of the Treatment. Recurrence is understood as the reappearance of clinical manifestations of a new episode of CDI that re-occurs within 8 weeks after the onset of symptoms of a previous episode that was resolved. | 8 weeks after the start of the treatment |
| Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment | Diarrhea resolution: <3 stools/24 hours for at least 2 consecutive days after the end of the treatment. | 72 hours after the start of the treatment |
| Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment | Diarrhea resolution: <3 stools/24 hours for at least 2 consecutive days after the end of the treatment. | 3 weeks after the start of the treatment |
| Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment | Diarrhea resolution: <3 stools/24 hours for at least 2 consecutive days after the end of the treatment. | 3 months after the start of the treatment |
| Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment | Diarrhea resolution: <3 stools/24 hours for at least 2 consecutive days after the end of the treatment. | 6 months after the start of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalisation | Time, in days, that the patient remains in the hospital as a result of CDI (but not necessarily indicating a recurrence of diarrhea due to CDI). | Up to 8 weeks after the start of the treatment |
| Good/Bad Progress of the Patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Cobo, MD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain | ||
| Hospital General Universitario de Alicante |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31883938 | Background | Reigadas E, Bouza E, Olmedo M, Vazquez-Cuesta S, Villar-Gomara L, Alcala L, Marin M, Rodriguez-Fernandez S, Valerio M, Munoz P. Faecal microbiota transplantation for recurrent Clostridioides difficile infection: experience with lyophilized oral capsules. J Hosp Infect. 2020 Jun;105(2):319-324. doi: 10.1016/j.jhin.2019.12.022. Epub 2019 Dec 26. | |
| 30221898 |
| Label | URL |
|---|---|
| EU Clinical Trials Register | View source |
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One selected patient was excluded before randomisation because of screening failure.
First patient was recruited on 29th October 2021. Last patient was recruited on 15th November 2023. Patients were recruited in the study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | MBK-01 | Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients). MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally. |
| FG001 | Fidaxomicin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 4, 2023 | Jul 5, 2024 |
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| Fidaxomicin | Drug | Oral administration of 200mg/12 hours of fidaxomicin for 10 days. |
|
|
A bad progress of the patient is defined as the detection 48-72 hours after the start of the treatment (MBK-01 or Fidaxomicin) of: A worsening of the diarrhea episode (at least one stool more than at baseline, baseline being understood as the time of the start of the study treatment (fidaxomicin or MBK01)). And, at least, one of the following factors:
|
| Up to 72 hours after the start of the treatment |
| Time to Recurrence Depending on Randomisation Groups | Recurrence: Reappearance of clinical manifestations of a new CDI episode in a patient with an CDI episode treated and cured in the previous 8 weeks. | Up to 6 months after the start of the treatment |
| Duration of Treatment | Duration in days of the treatment. | Up to 10 days |
| Overall Survival | Percentage of patients that are still alive after a defined period of time from the beginning of the treatment. | Up to 6 months after the start of the treatment |
| Number of Adverse Events Per Randomisation Group | Number of Adverse Events per randomisation group since baseline. | Up to 6 months after the start of the treatment |
| Type of Adverse Events Per Ramdomisation Group | Type of Adverse Events per ramdomisation group since baseline. | Up to 6 months after the start of the treatment |
| Number of Serious Adverse Events Per Ramdomisation Group | Number of Serious Adverse Events per ramdomisation group since baseline. | Up to 6 months after the start of the treatment |
| Type of Serious Adverse Events Per Ramdomisation Group | Type of Serious Adverse Events per ramdomisation group since baseline. | Up to 6 months after the start of the treatment |
| Adverse Events Related to the Treatment | Adverse Events related to the treatment since baseline. | Up to 6 months after the start of the treatment |
| Adverse Event Seriousness | Adverse Event Seriousness since baseline. | Up to 6 months after the start of the treatment |
| Adverse Events Related to the CDI | Adverse Events related to the CDI since baseline. | Up to 6 months after the start of the treatment |
| Mortality Associated With CDI | Percentage of patients that die due to CDI after a defined period of time from the beginning of the treatment. | Up to 6 months after the start of the treatment |
| Intensive Care Unit Admissions (ICU) | Percentage of patients admitted in the ICU after a defined period of time from the beginning of the treatment. | Up to 6 months after the start of the treatment |
| Adverse Events of Special Interest | Adverse Events of special interest since baseline. | Up to 6 months after the start of the treatment |
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | For each dimension (physical functioning, role limits-physical, bodily pain, general health, vitality, social functioning, role limits-emotional, mental health), the scale ranges from 0 (the worst health status for that dimension) to 100 (the best health status). | Day 0, 8 weeks and 6 months after the start of the treatment |
| Alicante |
| 03010 |
| Spain |
| Hospital Universitario de Cruces | Barakaldo | 48903 | Spain |
| Hospital Quirónsalud Barcelona | Barcelona | 08023 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario de Basurto | Bilbao | 48013 | Spain |
| Hospital Universitario Reina Sofía | Córdoba | 14004 | Spain |
| Hospital Universitario de Donostia | Donostia / San Sebastian | 20014 | Spain |
| Hospital Josep Trueta de Gerona | Girona | 17007 | Spain |
| Hospital San Pedro | Logroño | 26006 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | 28222 | Spain |
| Hospital Universitario Quirónsalud Madrid | Madrid | 28223 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | 07120 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Hospital Universitario de Araba | Vitoria-Gasteiz | 01009 | Spain |
| Hospital Clínico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Reigadas E, Olmedo M, Valerio M, Vazquez-Cuesta S, Alcala L, Marin M, Munoz P, Bouza E. Fecal microbiota transplantation for recurrent Clostridium difficile infection: Experience, protocol, and results. Rev Esp Quimioter. 2018 Oct;31(5):411-418. Epub 2018 Sep 14. |
Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intention To Treat (ITT) population: all patients randomized in the study, whether or not they fulfil inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | MBK-01 | Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients). MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally. |
| BG001 | Fidaxomicin | Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Medical history: number of previous pathologies | Mean | Standard Deviation | previous pathologies |
| |||||||||||||||
| Medical history: number of pretreatments | Mean | Standard Deviation | pretreatments |
| |||||||||||||||
| Clostridioides difficile infection episode | Count of Participants | Participants |
| ||||||||||||||||
| Previous antibiotic treatment | A pre-washing out period before the administration of the study treatment was mandatory for all patients who received previous antibiotic | In patients who received previous antibiotic treatment, the number of patients that carried out a pre-washing out period was analyzed. | Count of Participants | Participants |
| ||||||||||||||
| Duration of antibiotic treatment | n patients who received previous antibiotic treatment, the duration of the antibiotic treatment was analyzed. | Mean | Standard Deviation | days |
| ||||||||||||||
| Proton pump inhibitor treatment | Count of Participants | Participants |
| ||||||||||||||||
| SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | For each dimension (physical functioning, role limits-physical, bodily pain, general health, vitality, social functioning, role limits-emotional, mental health), the scale ranges from 0 (the worst health status for that dimension) to 100 (the best health status). | SF36 Questionnaire analysis was conducted in the population that completed the questionnaire | Mean | Standard Deviation | units on a scale |
| |||||||||||||
| Declared outcome of health | Declared outcome of health measured by SF36 questionnaire. The declared outcome of health is a transition item in The Short Form-36 Health Survey (SF-36). The results are measured as follows: 1 (excellent), (2) very good, 3 (good), 4 (regular) and 5 (poor). | Outcome analysis was conducted on the population that completed the SF36 questionnaire | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Absence of Diarrhea Due to Clostridiodes Difficile 8 Weeks After the Start of the Treatment | Number of patients who showed recurrence of at least one Episode of Diarrhea (3 or More Stools/24 Hours) 8 Weeks After the Start of the Treatment. Recurrence is understood as the reappearance of clinical manifestations of a new episode of CDI that re-occurs within 8 weeks after the onset of symptoms of a previous episode that was resolved. | For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons. | Posted | Count of Participants | Participants | 8 weeks after the start of the treatment |
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| Primary | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 72 Hours After the Start of the Treatment | Diarrhea resolution: <3 stools/24 hours for at least 2 consecutive days after the end of the treatment. | For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons. | Posted | Count of Participants | Participants | 72 hours after the start of the treatment |
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| Primary | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Weeks After the Start of the Treatment | Diarrhea resolution: <3 stools/24 hours for at least 2 consecutive days after the end of the treatment. | For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons. | Posted | Count of Participants | Participants | 3 weeks after the start of the treatment |
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| Primary | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 3 Months After the Start of the Treatment | Diarrhea resolution: <3 stools/24 hours for at least 2 consecutive days after the end of the treatment. | For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons. | Posted | Count of Participants | Participants | 3 months after the start of the treatment |
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| Primary | Absence of Diarrhea: Number of Episodes of Diarrhea (3 or More Stools/24 Hours) 6 Months After the Start of the Treatment | Diarrhea resolution: <3 stools/24 hours for at least 2 consecutive days after the end of the treatment. | For the analysis of recurrences, there are 77 patients evaluable. The remaining patients were excluded from this analysis due to different reasons. | Posted | Count of Participants | Participants | 6 months after the start of the treatment |
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| Secondary | Duration of Hospitalisation | Time, in days, that the patient remains in the hospital as a result of CDI (but not necessarily indicating a recurrence of diarrhea due to CDI). | Out of all partipants analyzed, only 14 in the MBK-01 group and 6 in the fidaxomicin group where hospitalised due to CDI. No participant received both treatments in any case. | Posted | Median | Inter-Quartile Range | days | Up to 8 weeks after the start of the treatment |
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| Secondary | Good/Bad Progress of the Patient | A bad progress of the patient is defined as the detection 48-72 hours after the start of the treatment (MBK-01 or Fidaxomicin) of: A worsening of the diarrhea episode (at least one stool more than at baseline, baseline being understood as the time of the start of the study treatment (fidaxomicin or MBK01)). And, at least, one of the following factors:
| The analysis is carried out on ITT population, excluding patients with no data related to this outcome | Posted | Count of Participants | Participants | Up to 72 hours after the start of the treatment |
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| Secondary | Time to Recurrence Depending on Randomisation Groups | Recurrence: Reappearance of clinical manifestations of a new CDI episode in a patient with an CDI episode treated and cured in the previous 8 weeks. | For the analysis of time to recurrence, there were 77 evaluable participants (37 in MBK-01 and 40 in fidaxomicin group). The reasons for non-evaluable were: MBK-01:
Fidaxomicin:
| Posted | Mean | Standard Error | weeks | Up to 6 months after the start of the treatment |
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| Secondary | Duration of Treatment | Duration in days of the treatment. | There are 46 evaluable patients in the Fidaxomicin group because 1 patient assigned to fidaxomicin was transferred to another hospital before first administration of the treatment. No patient received both treatments under any circumstances. | Posted | Median | Inter-Quartile Range | days | Up to 10 days |
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| Secondary | Overall Survival | Percentage of patients that are still alive after a defined period of time from the beginning of the treatment. | Posted | Count of Participants | Participants | Up to 6 months after the start of the treatment |
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| Secondary | Number of Adverse Events Per Randomisation Group | Number of Adverse Events per randomisation group since baseline. | Posted | Number | Number of Adverse Events | Up to 6 months after the start of the treatment |
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| Secondary | Type of Adverse Events Per Ramdomisation Group | Type of Adverse Events per ramdomisation group since baseline. | Posted | Number | Number of Adverse Events | Up to 6 months after the start of the treatment |
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| Secondary | Number of Serious Adverse Events Per Ramdomisation Group | Number of Serious Adverse Events per ramdomisation group since baseline. | Posted | Number | Number of Serious Adverse Events | Up to 6 months after the start of the treatment |
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| Secondary | Type of Serious Adverse Events Per Ramdomisation Group | Type of Serious Adverse Events per ramdomisation group since baseline. | Posted | Number | Number of Serious Adverse Events | Up to 6 months after the start of the treatment |
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| Secondary | Adverse Events Related to the Treatment | Adverse Events related to the treatment since baseline. | Posted | Number | Number of Adverse Events | Up to 6 months after the start of the treatment |
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| Secondary | Adverse Event Seriousness | Adverse Event Seriousness since baseline. | Posted | Number | Number of Adverse Events | Up to 6 months after the start of the treatment |
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| Secondary | Adverse Events Related to the CDI | Adverse Events related to the CDI since baseline. | Posted | Number | Number of Adverse Events | Up to 6 months after the start of the treatment |
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| Secondary | Mortality Associated With CDI | Percentage of patients that die due to CDI after a defined period of time from the beginning of the treatment. | Posted | Count of Participants | Participants | Up to 6 months after the start of the treatment |
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| Secondary | Intensive Care Unit Admissions (ICU) | Percentage of patients admitted in the ICU after a defined period of time from the beginning of the treatment. | Posted | Count of Participants | Participants | Up to 6 months after the start of the treatment |
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| Secondary | Adverse Events of Special Interest | Adverse Events of special interest since baseline. | Posted | Number | Number of AEs | Up to 6 months after the start of the treatment |
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| Secondary | SF36 Questionnaire (The Short Form-36 Health Survey) to Evaluate the Quality of Life | For each dimension (physical functioning, role limits-physical, bodily pain, general health, vitality, social functioning, role limits-emotional, mental health), the scale ranges from 0 (the worst health status for that dimension) to 100 (the best health status). | In addition to the lack of some data by different reasons through the study (i.e. dropout due to the use of forbidden medication), not all the patients completed all the visits. | Posted | Mean | Standard Deviation | score on a scale | Day 0, 8 weeks and 6 months after the start of the treatment |
|
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Up to 6 months after the start of the treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MBK-01 | Participants will receive MBK-01 capsules of fecal microbiota coming from healthy donors (45 patients). MBK-01: A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally. | 1 | 45 | 9 | 45 | 36 | 45 |
| EG001 | Fidaxomicin | Participants will receive Fidaxomicin (47 patients). Dificlir: Oral administration of 200mg/12 hours of fidaxomicin for 10 days. | 1 | 47 | 4 | 47 | 38 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dental discomfort | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Reflux gastritis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Medical device site reaction | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Polyp | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Clostridium test positive | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Microalbuminuria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vascular purpura | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Prophylaxis | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (26.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
The statistical power of the study was limited due to the small sample size, which may have prevented finding statistically significant differences between MBK-01 and fidaxomicin.
Additionally, the lack of available comparative studies between FMT and fidaxomicin in primary episodes of CDI in the literature limits the ability to contextualize our findings.
If the results are not submitted by the sponsor, the PI may publish them in scientific journals, provided that they mention the sponsor, at least, within the first year after the authorization and marketing in any country (for non-commercialized products). The sponsor must receive for review a copy of the text, except otherwise agreed, at least 45 days before the submission (20 days before for Abstracts). The PI may only use these data with prior express written authorization from the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olaia Aurtenetxe Saez | Mikrobiomik Healthcare Company S.L. | +34 944 540 166 | ensayosclinicos@mikrobiomik.net |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2023 | Jul 5, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D000077732 | Fidaxomicin |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
|
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| Amerindian |
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| Asian |
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| Other |
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| Recurrent episode |
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| Pre-washing out |
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| Physical role |
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| Bodily pain |
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| General health |
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| Vitality |
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| Social function |
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| Emotional role |
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| Mental health |
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