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Study is terminated for futility per protocol-specified interim analysis and DMC recommendation.
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The purpose of this study is to determine whether Fecal Microbiota Therapy (FMT) is effective vs. placebo in the prevention of C. difficile infection recurrence.
Clostridium difficile infection (CDI) is one of the most common nosocomial infections and is increasingly seen in non-hospitalized patients. Although more than 90% of patients have symptom resolution with a course of standard antimicrobial therapy, subsequent recurrence rates range from 15-30% (after the first CDI episode) to 40-50% (after the second and subsequent episodes). Fecal microbiota transplantation (FMT) has shown promise as an adjunct to standard antimicrobial therapy, reducing recurrence among FMT recipients to 15%.
The primary study goal is to assess the efficacy of FMT for the prevention of subsequent recurrent CDI, when administered after successful treatment of recurrent CDI with standard antimicrobial therapy. Secondary goals are to evaluate, the efficacy of FMT in terms of CDI severity, duration, the safety of FMT, and in the event of a positive study result, establish a mechanism for providing FMT within the VA system.
This study will enroll 390 participants. Participants will be randomized (1:1 ratio) to FMT or placebo, stratified by number of prior recurrent CDI episodes (1 versus >1). They will be assessed for symptoms of CDI, other study outcomes and any treatment-related adverse events at 2, 14, 28, 42, and 56 days, and month 3, 4, 5 and 6 after administration of the study treatment.
The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization.
Definite recurrence is defined as any of the following: The new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis; Other clinical symptoms including ileus, toxic megacolon, or colectomy; plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test. Possible recurrence is defined as the same clinical manifestations as above, but without laboratory confirmation of C. difficile (stool test not sent, negative EIA toxin test result, or uninterpretable result).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Fecal Microbiota Therapy (FMT) |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Therapy (FMT) | Drug | Oral capsule-delivered FMT |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death | The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test. | Within 56 days of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization. | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitri M Drekonja, MD | Minneapolis VA Health Care System, Minneapolis, MN | Study Chair |
| Aasma Shaukat, MD MPH | Minneapolis VA Health Care System, Minneapolis, MN | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34154439 | Result | Drekonja DM, Shaukat A, Zhang JH, Reinink AR, Nugent S, Dominitz JA, Davis-Karim A, Gerding DN, Kyriakides TC. Microbiota or placebo after antimicrobial therapy for recurrent Clostridioides difficile at home: A clinical trial with novel home-based enrollment. Clin Trials. 2021 Oct;18(5):622-629. doi: 10.1177/17407745211021198. Epub 2021 Jun 22. | |
| 39271107 |
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Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (CSP). Study data held for this purpose may include data, data content, format, and organization. The data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible.
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The study did not contain pre-assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fecal Microbiota Therapy | Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT |
| FG001 | Placebo | Placebo Placebo: Oral capsule-delivered placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all participants who were randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Fecal Microbiota Therapy (FMT) | Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT |
| BG001 | Placebo | Placebo Placebo: Oral capsule-delivered placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death | The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test. | All randomized participants are analyzed according to the principle of intent-to-treat. | Posted | Count of Participants | Participants | Within 56 days of randomization |
|
All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment).
The study definition is consistent with those definitions in ClinicalTrials.gov
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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 | Fecal Microbiota Therapy (FMT) | Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuan Huang, Ph.D., Biostatistician | VA Cooperative Studies Program | 2039325711 | yuanhuang1@va.gov |
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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 | May 2, 2022 | Aug 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 4, 2019 | Aug 22, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2022 | Jul 11, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D003141 | Communicable Diseases |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Drug |
Oral capsule-delivered placebo |
|
| Within 6 months of randomization |
| Quality of Life at 56 Day | The investigators will use a brief assessment of both overall and gastrointestinal health status, a previously validated instrument called Gastrointestinal Quality of Life Index (GIQLI). GIQLI takes value between 0 and 144, with higher score associated with better quality of life. | 56 days from randomization |
| Frequency of Possible CDI Recurrences Within 6 Months of Randomization | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. | Within 6 months of randomization |
| Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR) | This is similar to a possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test and PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. | Within 56 days of randomization |
| Occurrence of Abdominal Pain Among All Possible CDI Recurrences. | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced abdominal pain in each of their possible CDI recurrences. | Within 6 months of randomization |
| Definite Recurrent CDI | The occurrence of definite recurrent CDI within 56 days of randomization. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test. | Within 56 days of randomization |
| Possible Recurrent CDI | The occurrence of possible recurrent CDI within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. | Within 56 days of randomization |
| Death | The occurrence of death within 56 days of randomization. | Within 56 days of randomization |
| Diarrhea That is Negative for C. Difficile by EIA Toxin Testing But Positive by PCR | This is similar to possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test but positive by PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. | Within 56 days of randomization |
| Occurrence of Urgency Among All Possible CDI Recurrences. | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced urgency in each of their possible CDI recurrences. The urgency is defined as the urgent need to pass stool, feelings of incomplete bowel control, or inability to control defecation. | within 6 months from randomization |
| Occurrence of Fecal Incontinence Among All Possible CDI Recurrences. | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced fecal incontinence in each of their possible CDI recurrences. Fecal incontinence is defined as having unintentional passing of stool (liquid or solid). | within 6 months from randomization |
| Occurrence of Altering Life Style Among All Possible CDI Recurrences | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they had to alter their life style (such as using pads) in each of the possible CDI recurrence. | within 6 months of randomization |
| Drekonja DM, Shaukat A, Huang Y, Zhang JH, Reinink AR, Nugent S, Dominitz JA, Davis-Karim A, Gerding DN, Kyriakides TC. A Randomized Controlled Trial of Efficacy and Safety of Fecal Microbiota Transplant for Preventing Recurrent Clostridioides difficile Infection. Clin Infect Dis. 2025 Feb 5;80(1):52-60. doi: 10.1093/cid/ciae467. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race is a multiple-choice question | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Albumin | baseline labs were not available for a few participants | Mean | Standard Deviation | g/dL |
|
| OG000 | Fecal Microbiota Therapy (FMT) | Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT |
| OG001 | Placebo | Placebo Placebo: Oral capsule-delivered placebo |
|
|
| Secondary | Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization. | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test. | Intent-to-treat | Posted | Count of Participants | Participants | Within 6 months of randomization |
|
|
|
| Secondary | Quality of Life at 56 Day | The investigators will use a brief assessment of both overall and gastrointestinal health status, a previously validated instrument called Gastrointestinal Quality of Life Index (GIQLI). GIQLI takes value between 0 and 144, with higher score associated with better quality of life. | Intent-to-treat & complete-case | Posted | Mean | Standard Deviation | units on a scale | 56 days from randomization |
|
|
|
| Secondary | Frequency of Possible CDI Recurrences Within 6 Months of Randomization | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. | Intent-to-treat | Posted | Count of Participants | Participants | Within 6 months of randomization |
|
|
|
| Secondary | Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR) | This is similar to a possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test and PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. | intent-to-treat | Posted | Count of Participants | Participants | Within 56 days of randomization |
|
|
|
| Secondary | Occurrence of Abdominal Pain Among All Possible CDI Recurrences. | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced abdominal pain in each of their possible CDI recurrences. | intent-to-treat | Posted | Count of Units | Recurrences | Within 6 months of randomization | Recurrences | Recurrences |
|
|
|
| Secondary | Definite Recurrent CDI | The occurrence of definite recurrent CDI within 56 days of randomization. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test. | intent-to-treat | Posted | Count of Participants | Participants | Within 56 days of randomization |
|
|
|
| Secondary | Possible Recurrent CDI | The occurrence of possible recurrent CDI within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. | intent-to-treat | Posted | Count of Participants | Participants | Within 56 days of randomization |
|
|
|
| Secondary | Death | The occurrence of death within 56 days of randomization. | intent-to-treat | Posted | Count of Participants | Participants | Within 56 days of randomization |
|
|
|
| Secondary | Diarrhea That is Negative for C. Difficile by EIA Toxin Testing But Positive by PCR | This is similar to possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test but positive by PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. | intent-to-treat | Posted | Count of Participants | Participants | Within 56 days of randomization |
|
|
|
| Secondary | Occurrence of Urgency Among All Possible CDI Recurrences. | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced urgency in each of their possible CDI recurrences. The urgency is defined as the urgent need to pass stool, feelings of incomplete bowel control, or inability to control defecation. | intent-to-treat | Posted | Count of Units | Recurrences | within 6 months from randomization | Recurrences | Recurrences |
|
|
|
| Secondary | Occurrence of Fecal Incontinence Among All Possible CDI Recurrences. | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced fecal incontinence in each of their possible CDI recurrences. Fecal incontinence is defined as having unintentional passing of stool (liquid or solid). | intent-to-treat | Posted | Count of Units | Recurrences | within 6 months from randomization | Recurrences | Recurrences |
|
|
|
| Secondary | Occurrence of Altering Life Style Among All Possible CDI Recurrences | A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they had to alter their life style (such as using pads) in each of the possible CDI recurrence. | intent-to-treat | Posted | Count of Units | Recurrences | within 6 months of randomization | Recurrences | Recurrences |
|
|
|
| 1 |
| 76 |
| 17 |
| 76 |
| 19 |
| 76 |
| EG001 | Placebo | Placebo Placebo: Oral capsule-delivered placebo | 5 | 77 | 21 | 77 | 28 | 77 |
| cardiac failure | Cardiac disorders | Systematic Assessment |
|
| atrioventricular block | Cardiac disorders | Systematic Assessment |
|
| cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| gastrointestinal vascular malformation haemorrhagic | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| faecalomna | Gastrointestinal disorders | Systematic Assessment |
|
| haematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| stent-graft endoleak | General disorders | Systematic Assessment |
|
| colicholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| cirrhosis alcoholic | Hepatobiliary disorders | Systematic Assessment |
|
| solid organ transplant rejection | Immune system disorders | Systematic Assessment |
|
| clostridium difficile infection | Infections and infestations | Systematic Assessment |
|
| sepsis | Infections and infestations | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | Systematic Assessment |
|
| cellulitis | Infections and infestations | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | Systematic Assessment |
|
| gastroenteritis viral | Infections and infestations | Systematic Assessment |
|
| meningitis viral | Infections and infestations | Systematic Assessment |
|
| peritonitis bacterial | Infections and infestations | Systematic Assessment |
|
| urosepsis | Infections and infestations | Systematic Assessment |
|
| colonoscopy | Investigations | Systematic Assessment |
|
| metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
|
| post-traumatic stress disorder | Psychiatric disorders | Systematic Assessment |
|
| major depression | Psychiatric disorders | Systematic Assessment |
|
| nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| nephrotic syndrome | Renal and urinary disorders | Systematic Assessment |
|
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hypertensive emergency | Vascular disorders | Systematic Assessment |
|
| peripheral vein occlusion | Vascular disorders | Systematic Assessment |
|
| Dafaecation urgency | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| gastrointestinal hypermotility | Gastrointestinal disorders | Systematic Assessment |
|
| anorectal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | Systematic Assessment |
|
| gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| haematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| fatigua | General disorders | Systematic Assessment |
|
| pyrexia | General disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| rectal abscess | Infections and infestations | Systematic Assessment |
|
| gastritis viral | Infections and infestations | Systematic Assessment |
|
| gastroenteritis | Infections and infestations | Systematic Assessment |
|
| nasopharygnigitis | Infections and infestations | Systematic Assessment |
|
| tooth fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| renal function test abnormal | Investigations | Systematic Assessment |
|
| white blood cell count increased | Investigations | Systematic Assessment |
|
| stool analysis abnormal | Investigations | Systematic Assessment |
|
| urine output increased | Investigations | Systematic Assessment |
|
| decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| taste disorder | Nervous system disorders | Systematic Assessment |
|
| haematuria | Renal and urinary disorders | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hypertension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| Have two possible CDI recurrences |
|
| Have three possible CDI recurrences |
|