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Microbial Therapy

FMT Administration for Bowel Incontinence (FMT for FI Trial)

Phase 1 & 2

Waitlist Available

Led By Uduak U Andy, MD

Research Sponsored by University of Pennsylvania

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 6 months

Awards & highlights

FMT for FI Trial Summary

This trial is testing whether a fecal transplant can help treat fecal incontinence in older women.

FMT for FI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine if fecal microbial transplantation leads to clinical improvement in refractory fecal incontinence in older women.

Determine the safety of FMT administration via naso-gastric tube in older women with FI.

Secondary outcome measures

Determine if FMT leads to improved quality of life for subjects.

Determine if the effectiveness of microbial engraftment following fecal microbial transplantation is associated with the degree of clinical improvement.

Other outcome measures

Determine whether the baseline microbiota of the subject affects engraftment in fecal microbial transplantation for fecal incontinence.

FMT for FI Trial Design

1Treatment groups

Experimental Treatment

Group I: FMT AdministrationExperimental Treatment1 Intervention

This is a single arm study in which all eligible participants will receive FMT.

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,050 Total Patients Enrolled

Uduak U Andy, MDPrincipal InvestigatorUniversity of Pennsylvania

2 Previous Clinical Trials

430 Total Patients Enrolled

Frequently Asked Questions

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

What is the current quota of participants for this medical trial?

"Affirmative. Clinicaltrials.gov has information which affirms that this venture is in pursuit of participants, first published on January 14th 2021 and modified as recently as September 28th 2022. Fifteen individuals are sought out from a single medical facility."

Answered by AI

Are any new volunteers being accepted for this experiment?

"As per clinicaltrials.gov, enrollment for this medical experiment is ongoing. It was posted online on the 14th of January 2021 and recently revised on September 28th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women

2021. "Fecal Microbial Transplantation for the Treatment of Fecal Incontinence in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04201821.