Fecal Microbiota Transplantation for Clostridium Difficile Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UMass Memorial Medical Center, Worcester, MAClostridium Difficile Infection+1 MoreFecal Microbiota Transplantation - Procedure
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether stool transplant can effectively treat recurrent C. diff infection by replenishing good bacteria in the colon.

Eligible Conditions
  • Clostridium Difficile Infection Recurrence
  • Clostridium Difficile (C. diff) Infection

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
Clostridium Difficile (C. diff) resolution'

Trial Safety

Side Effects for

Treatment
44%Diarrhea
26%Abdominal Pain
16%Rectal Bleeding
12%Constiption
10%Nausea
10%Fever
6%Vomiting
6%Fatigue
4%Heart Burn
4%Migraine
4%Chills
4%Yeast Infection
2%Anemia
2%IBD Flare
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT03106844) in the Treatment ARM group. Side effects include: Diarrhea with 44%, Abdominal Pain with 26%, Rectal Bleeding with 16%, Constiption with 12%, Nausea with 10%.

Trial Design

1 Treatment Group

Fecal Microbiota Transplantation
1 of 1

Experimental Treatment

500 Total Participants · 1 Treatment Group

Primary Treatment: Fecal Microbiota Transplantation · No Placebo Group · N/A

Fecal Microbiota Transplantation
Procedure
Experimental Group · 1 Intervention: Fecal Microbiota Transplantation · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2016
Completed Phase 2
~330

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Krunal PatelLead Sponsor

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

What is the population size of participants in this experimental research?

"Affirmative. According to clinicaltrials.gov, this investigation is actively seeking participants. The trial was initially listed on January 16th 2014 and more recently updated on October 3rd 2021; it needs 500 people at one medical facility to contribute data." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies available for participants of this research study?

"Indeed, this medical study is currently welcoming participants. Clinicaltrials.gov states that the trial was first published on January 16th 2014 and its most recent update occured on October 3rd 2021." - 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.