Clostridium Difficile Infection RecurrencePhase 2NCT03617445
Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
A Phase 2 study testing FMT oral capsule and Oral Vancomycin in people with Clostridium Difficile Infection Recurrence, run by University of Wisconsin, Madison at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection Recurrence
- What is being tested?
- FMT oral capsule and Oral Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 5 sitesUnited States
- Study dates
- 3 Aug 2022to 1 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is willing to provide written informed consent.
- Is willing to comply with all study procedures and be available for the duration of the study.
- Can take oral medication
- At least 18 years of age.
- Is a solid organ transplant (SOT) recipient
- Has had at recurrent C. difficile infection defined as: positive C. difficile testing in stool and diarrhea (three or more loose stools over 24 hours) during the 180 day period following completion of treatment for prior episode
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- History of positive IgG test to cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) for subject or donor
- Clinical response to 4-14 days of oral antibiotic standard of care treatment for the current episode of CDI. Clinical response is defined as greater than or equal to 25% reduction of diarrhea.
- Negative urine or serum pregnancy test for women of childbearing potential and agree to use effective form of contraception until 6 weeks post treatment
Who cannot join
- Major bowel resection surgery within 90 days of randomization
- Active intestinal disease (e.g. Crohn's disease, ulcerative colitis)
- History of total colectomy or bariatric surgery
- Known or suspected toxic megacolon and/or small bowel ileus
- Presence of colostomy or ileostomy.
- Taking concomitant antibiotics within 48 hours of Visit 2. Topical antibiotics, and antibiotics for transplant prophylaxis are permitted
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- Dysphagia; oropharyngeal, S), or patient has evidence of dysphagia when the 'safety test' capsule is administered
- Currently receiving medication for treatment of acute rejection and/or develop acute rejection prior to administration of FMT
- Active, Severe Gastroparesis
- Unwilling to withhold probiotics. Probiotics include supplements, prescriptions, and non-prescriptions. Foods (like yogurt) are not prohibited
- Neutropenia, ≤ 500 neutrophils/ml [noted in medical records and resulted within 7 days of Visit 1])
- Symptomatic co-infection with another intestinal pathogen as determined by chart review
- Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for any active malignancy. Patients on maintenance chemotherapy could be enrolled after consultation with the study Medical Monitor
- Any severe food allergy, defined as a history of anaphylaxis, systemic urticarial or angioedema attributed to a food and requiring current avoidance precautions
- Expected life expectancy is less than 6 months
- Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
- Women who are pregnant, lactating or planning on becoming pregnant during the study
- Not suitable for study participation due to other reasons at the discretion of the investigators
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Indiana University
Indianapolis, Indiana, 46202
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
Mayo Clinic
Rochester, Minnesota, 55902
About this study
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.
Read the detailed description
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.
- Being tested
- FMT oral capsule, Oral Vancomycin, FMT oral placebo, Oral Vancomycin placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT oral capsuleDrug
Also called MTP-101-C
FMT oral capsules, single dose of 5 capsules
Oral VancomycinDrug
Also called 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 placeboDrug
Also called Placebo MTP-101-C
Placebo oral capsules, single dose of 5 capsules
Oral Vancomycin placeboDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| FMT oral capsules/ oral vancomycin placebo | Active comparator | FMT plus placebo vancomycin Receives: Drug: FMT oral capsule; Drug: Oral Vancomycin placebo |
| Placebo FMT capsules/ Active oral vancomycin | Active comparator | Vancomycin plus FMT enema placebo Receives: Drug: Oral Vancomycin; Drug: FMT oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 60 consecutive days
Secondary outcomes (4)
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.
Measured: Weeks 4, 29 weeks
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
Measured: 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
Measured: 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
Measured: up to 30 weeks of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start3 Aug 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Why it stopped: Study drug not available due to COVID-19 FDA restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium Difficile Infection RecurrenceStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasia Safdar, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617445
- Sponsor's protocol ID
- 2018-1056
- Other IDs
- A534265, SMPH/MEDICINE/INFECT DIS, Protocol Version 8/24/2022, 1U01AI125053-01A1
- Status last verified
- Dec 2024
- First submitted
- 27 Jul 2018
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT03617445
- Acronym / sponsor ID
- 2018-1056
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study drug not available due to COVID-19 FDA restrictions
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FMT oral capsules/ oral vancomycin placebo | Active comparator | Drug: FMT oral capsule, Drug: Oral Vancomycin placeboFMT plus placebo vancomycin |
| Placebo FMT capsules/ Active oral vancomycin | Active comparator | Drug: Oral Vancomycin, Drug: FMT oral placeboVancomycin plus FMT enema placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is willing to provide written informed consent.
- Is willing to comply with all study procedures and be available for the duration of the study.
- Can take oral medication
- At least 18 years of age.
- Is a solid organ transplant (SOT) recipient
Key exclusion criteria (18 listed)
- Major bowel resection surgery within 90 days of randomization
- Active intestinal disease (e.g. Crohn's disease, ulcerative colitis)
- History of total colectomy or bariatric surgery
- Known or suspected toxic megacolon and/or small bowel ileus
- Presence of colostomy or ileostomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMT oral capsuleAlso: MTP-101-CFMT oral capsules, single dose of 5 capsules | Drug | FMT oral capsules/ oral vancomycin placebo |
| Oral VancomycinAlso: vancomycinOral 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 | Drug | Placebo FMT capsules/ Active oral vancomycin |
| FMT oral placeboAlso: Placebo MTP-101-CPlacebo oral capsules, single dose of 5 capsules | Drug | Placebo FMT capsules/ Active oral vancomycin |
| Oral Vancomycin placeboAlso: placeboPlacebo 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. | Drug | FMT oral capsules/ oral vancomycin placebo |
Primary outcome
Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin
Time frame: 60 consecutive days
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)
4 secondary outcomes
CDI-related Quality of Life (QOL) Compared Using Treatment and Time Interaction as Model Terms While Adjusting for Potential Confounders
Time frame: Weeks 4, 29 weeks
Compare the Change in Gut Microbiota and Evaluate Changes in Microbiota to Assess for Safety of FMT in Patients
Time frame: up to 30 weeks of study participation
Number of Patients Who Experienced Short or Medium Term Adverse Events
Time frame: 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
Time frame: up to 30 weeks of study participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasia Safdar, MD, PhD principal investigator
University of Wisconsin, Madison
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT oral capsule and Oral Vancomycin in people with Clostridium Difficile Infection Recurrence, run by University of Wisconsin, Madison at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin (time frame: 60 consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.