Fecal microbiota transplantation for Pouchitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
McMaster University, Hamilton, CanadaPouchitisFecal microbiota transplantation - Other
Eligibility
18 - 99
All Sexes
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Study Summary

This trial will test whether a poop transplant can help people with pouchitis, a serious gut disorder.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Fecal Microbiota Transplantation
1
Pembrolizumab
1
Fecal Microbiota Transplantation (FMT)

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 7 weeks

7 weeks
Remission of pouchitis, defined as a pouchitis disease activity index (PDAI) score of <7, with a decreased from baseline PDAI score of 3 points
compare the fecal microbiome in pouchitis patients in remission versus still active at the end of the trial.
compliance of patients who receive FMT

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Fecal Microbiota Transplantation
2
Pembrolizumab
1
Fecal Microbiota Transplantation (FMT)

Side Effects for

Donors Feces
8%fever
8%abdominal pain
8%fecal urgency
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03378921) in the Donors Feces ARM group. Side effects include: fever with 8%, abdominal pain with 8%, fecal urgency with 8%.

Trial Design

2 Treatment Groups

FMT
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

34 Total Participants · 2 Treatment Groups

Primary Treatment: Fecal microbiota transplantation · Has Placebo Group · Phase 2

FMT
Other
Experimental Group · 1 Intervention: Fecal microbiota transplantation · Intervention Types: Other
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebos · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 weeks

Who is running the clinical trial?

McMaster UniversityLead Sponsor
820 Previous Clinical Trials
1,731,701 Total Patients Enrolled

Eligibility Criteria

Age 18 - 99 · All Participants · 3 Total Inclusion Criteria

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References

Frequently Asked Questions

Does this research involve participants who are over 75 years old?

"The age limit for this trial is set at 18 years or older and 99 years or younger." - Anonymous Online Contributor

Unverified Answer

Does the FDA condone fecal microbiota transplantation as a viable medical procedure?

"Fecal microbiota transplantation is in Phase 2 of clinical trials, so there is some data supporting its safety. However, because this treatment is still in development, there is no data yet to support its efficacy." - Anonymous Online Contributor

Unverified Answer

How many total individuals are being research in this investigation?

"According to the information available on clinicaltrials.gov, this trial is currently looking for patients to enroll. The posting dates for this trial are from April 17th, 2019 to present, with the last edit happening on April 5th, 2022. So far, 34 people have been enrolled at 1 location." - Anonymous Online Contributor

Unverified Answer

Are new patients currently being recruited for this trial?

"The most up-to-date information on clinicaltrials.gov shows that this study is still recruiting patients. This trial was originally posted on April 17th, 2019 and last updated on April 5th, 2022." - Anonymous Online Contributor

Unverified Answer

Are there any medical or age restrictions for patients who want to participate in this clinical trial?

"The ideal candidate for this trial is aged 18-99, has a current diagnosis of pouchitis, and meets the other listed inclusion criteria." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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