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Microbiota Transplant

FMT oral capsule for Clostridium Difficile Infection

Phase 2

Waitlist Available

Led By Nasia Safdar, MD, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, week 4 and at 29 weeks

Awards & highlights

Study Summary

This trial is testing whether Fecal Microbiota Transplantation (FMT) is more effective than vancomycin for curing recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients.

Eligible Conditions

Clostridium Difficile Infection Recurrence

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, week 4 and at 29 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, week 4 and at 29 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 4 and at 29 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare the rate of recurrence of CDI in solid organ transplant recipients with FMT compared with oral vancomycin

Secondary outcome measures

CDI-related QOL

Compare the change in gut microbiota and evaluate the association between the change in gut microbiota and recurrence of CDI

Vancomycin

+1 more

Trial Design

2Treatment groups

Active Control

Group I: FMT oral capsules/ oral vancomycin placeboActive Control2 Interventions

FMT plus placebo vancomycin

Group II: Placebo FMT capsules/ Active oral vancomycinActive Control2 Interventions

Vancomycin plus FMT enema placebo

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,384 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,268 Previous Clinical Trials

5,481,129 Total Patients Enrolled

Nasia Safdar, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

1 Previous Clinical Trials

1 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical treatment have regulatory clearance from the FDA?

"Our team at Power ranked the safety of this treatment a 2, as it is currently in Phase 2 trials. Therefore, some data exists that confirms its security but no evidence has been found to suggest efficacy."

Answered by AI

Are recruits currently being taken on for this research?

"Affirmative. Clinicaltrials.gov exhibits this research is presently looking for contributors, with the trial first posted on August 3rd 2022 and modified last on September 14th 2022. The study requires 158 patients to be enrolled from 5 distinct locations."

Answered by AI

Are there any American hospitals participating in the clinical trial?

"This trial is being administered from five distinct locations, among them Chicago, Indianapolis and Rochester. To reduce your commuting burden during the study period it might be best to enroll at a site near you."

Answered by AI

How many participants are being enrolled in this experiment?

"This clinical trial necessitates 158 eligible participants to take part, and individuals can apply from multiple locations such as Northwestern University in Chicago, Illinois or Indiana University in Indianapolis, Indiana."

Answered by AI

Is there evidence to suggest that this treatment has been successful in the past?

"Presently, 55 studies are actively exploring this intervention with 6 of those trials in their final stage. Most investigations into this therapy take place within Jupiter, Florida; however, 315 other medical centres have clinical trials taking place as well."

Answered by AI

What medical ailments can this therapy be employed to address?

"This treatment is intended to address staphylococcal infections, infection caused by staphylococci and enterocolitis induced by Staphylococcus aureus."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients

2022. "Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03617445.