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| ID | Type | Description | Link |
|---|---|---|---|
| A534265 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/INFECT DIS | Other Identifier | UW Madison | |
| Protocol Version 8/24/2022 | Other Identifier | UW Madison | |
| 1U01AI125053-01A1 | U.S. NIH Grant/Contract | View source |
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Study drug not available due to COVID-19 FDA restrictions
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.
Clostridium difficile (C.difficile) is a pathogen of major public health importance, especially in individuals with comorbid conditions such as solid organ transplantation (SOT). The incidence and adverse outcomes of CDI are greatly amplified in the setting of SOT, due to healthcare exposure, antibiotic use and immunosuppression, all of which are ubiquitous in SOT recipients. There are currently no effective treatment options to achieve a sustained cure of recurrent CDI and prevent further recurrence in SOT recipients. A novel approach that has recently gained attention is restoration of the CDI impaired gut microbiome by instillation of stool from a healthy donor into the intestine of a CDI patient. This treatment, called Fecal Microbiota Transplantation (FMT) has been found in non-comparative studies to reduce CDI recurrence dramatically with a reported efficacy of over 95%, however its efficacy in SOT recipients has not been studied and cannot be extrapolated from results in the non-SOT population because SOT recipients are a unique study population due to profound immunosuppression, frequent antibiotic use and frequent opportunities for exposure to CDI all of which markedly, repeatedly and persistently disrupt the gut microbiome. Thus, this critical gap in the field needs to be addressed by a trial of FMT in SOT recipients with CDI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT oral capsules/ oral vancomycin placebo | Active Comparator | FMT plus placebo vancomycin |
|
| Placebo FMT capsules/ Active oral vancomycin | Active Comparator | Vancomycin plus FMT enema placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT oral capsule | Drug | FMT oral capsules, single dose of 5 capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin | Recurrence is defined as diarrhea (greater or equal to 3 or more loose stools that take the shape of the collection container in a 24 hr period) | 60 consecutive days |
| Measure | Description | Time Frame |
|---|---|---|
| CDI-related Quality of Life (QOL) Compared Using Treatment and Time Interaction as Model Terms While Adjusting for Potential Confounders | Cdiff32 32-item questionnaire, with a range of 0 to 100, with 100 representing the best score, and 0 representing the worst score. Dietary component of the questionnaire linked to any stool microbiome data to determine whether diet influences gut microbiota. | Weeks 4, 29 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nasia Safdar, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Indiana University |
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consent
medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | FMT Oral Capsules/ Oral Vancomycin Placebo | FMT plus placebo vancomycin FMT oral capsule: FMT oral capsules, single dose of 5 capsules Oral Vancomycin placebo: Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2022 |
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This is a phase 2, double blind, doubly placebo-controlled, randomized trial assessing the treatment effects of FMT compared to oral Vancomycin for recurrent CDI in solid organ transplant recipients.
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| Oral Vancomycin | Drug | Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days |
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| FMT oral placebo | Drug | Placebo oral capsules, single dose of 5 capsules |
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| Oral Vancomycin placebo | Drug | Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days. |
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| Compare the Change in Gut Microbiota and Evaluate Changes in Microbiota to Assess for Safety of FMT in Patients | Using multiple metric of microbiota structure and function, analyze gut microbiome samples to evaluate the association between change in gut microbiome and recurrent CDI | up to 30 weeks of study participation |
| Number of Patients Who Experienced Short or Medium Term Adverse Events | List and evaluate all short- and medium-term safety events as defined in the study protocol for the safety of FMT in SOT patients | Up 30 weeks of study participation |
| Compare the Effects of FMT and Oral Vancomycin on Intestinal Colonization by Multi-drug-resistant Organisms Other Than C. Difficile in SOT Patients | Analysis all stool samples and compare the effects of FMT and oral vancomycin on intestinal colonization with multi-drug resistant organisms (other than C. difficile) in SOT patients | up to 30 weeks of study participation |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53792 | United States |
| FG001 | Placebo FMT Capsules/ Active Oral Vancomycin | Vancomycin plus FMT enema placebo Oral Vancomycin: Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days FMT oral placebo: Placebo oral capsules, single dose of 5 capsules |
| COMPLETED |
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| NOT COMPLETED |
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Low subject accrual
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| ID | Title | Description |
|---|---|---|
| BG000 | FMT Oral Capsules/ Oral Vancomycin Placebo | FMT plus placebo vancomycin FMT oral capsule: FMT oral capsules, single dose of 5 capsules Oral Vancomycin placebo: Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days. |
| BG001 | Placebo FMT Capsules/ Active Oral Vancomycin | Vancomycin plus FMT enema placebo Oral Vancomycin: Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days FMT oral placebo: Placebo oral capsules, single dose of 5 capsules |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin | Recurrence is defined as diarrhea (greater or equal to 3 or more loose stools that take the shape of the collection container in a 24 hr period) | Target enrollment was not met and data cannot be compared as all enrolled subjects were randomized to 1 arm only. | Posted | Count of Participants | Participants | 60 consecutive days |
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| Secondary | CDI-related Quality of Life (QOL) Compared Using Treatment and Time Interaction as Model Terms While Adjusting for Potential Confounders | Cdiff32 32-item questionnaire, with a range of 0 to 100, with 100 representing the best score, and 0 representing the worst score. Dietary component of the questionnaire linked to any stool microbiome data to determine whether diet influences gut microbiota. | Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report. | Posted | Weeks 4, 29 weeks |
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| Secondary | Compare the Change in Gut Microbiota and Evaluate Changes in Microbiota to Assess for Safety of FMT in Patients | Using multiple metric of microbiota structure and function, analyze gut microbiome samples to evaluate the association between change in gut microbiome and recurrent CDI | Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report. | Posted | No | up to 30 weeks of study participation |
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| Secondary | Number of Patients Who Experienced Short or Medium Term Adverse Events | List and evaluate all short- and medium-term safety events as defined in the study protocol for the safety of FMT in SOT patients | Target enrollment was not reached and all subjects were randomized to 1 arm only, so planned analyses cannot be performed. | Posted | Count of Participants | Participants | Up 30 weeks of study participation |
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| Secondary | Compare the Effects of FMT and Oral Vancomycin on Intestinal Colonization by Multi-drug-resistant Organisms Other Than C. Difficile in SOT Patients | Analysis all stool samples and compare the effects of FMT and oral vancomycin on intestinal colonization with multi-drug resistant organisms (other than C. difficile) in SOT patients | Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report. | Posted | up to 30 weeks of study participation |
|
30 weeks
No differences from standard definition of adverse events. Adverse events are inquired upon during weekly visits and follow-up phone visits by study staff.
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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 | FMT Oral Capsules/ Oral Vancomycin Placebo | FMT plus placebo vancomycin FMT oral capsule: FMT oral capsules, single dose of 5 capsules Oral Vancomycin placebo: Placebo oral vancomycin capsules every 6 hours for 14 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Placebo FMT Capsules/ Active Oral Vancomycin | Vancomycin plus FMT enema placebo Oral Vancomycin: Oral Vancomycin 125 mg capsules every 6 hours for 14 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days FMT oral placebo: Placebo oral capsules, single dose of 5 capsules | 0 | 3 | 1 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to toe infection | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nasia Safdar | University of Wisconsin-Madison | 608-263-1545 | ns2@medicine.wisc.edu |
| Jun 3, 2024 |
| Prot_SAP_005.pdf |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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