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Fecal Microbiota Transplantation

Fecal Microbiota Transplant for Clostridium Difficile Colitis

Phase 2
Recruiting
Led By Gary M Cox, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Study entry is open to adults (>18 years old) who have had three or more episodes of Clostridium difficile colitis within the previous 12 months.
Be older than 18 years old
Must not have
Diagnosis of inflammatory bowel disease (e.g. Crohn's or ulcerative colitis)
Inability to swallow capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether transplanting stool from healthy donors in capsule form can help treat recurrent colitis caused by Clostridium difficile.

Who is the study for?
This trial is for adults over 18 who've had at least three episodes of C. difficile colitis in the past year. It's not for those with very low white blood cell counts, tube feedings, pregnant women, short life expectancy, trouble swallowing pills, certain stomach surgeries or conditions requiring IV nutrition, other active infections needing antibiotics, recent chemotherapy, inflammatory bowel diseases like Crohn's or ulcerative colitis, or untreated intestinal parasites.
What is being tested?
The trial is testing stool transplants to treat stubborn C. difficile colitis. Healthy donor stool is made into capsules that participants take by mouth to restore normal bacteria in their bowels and combat the infection.
What are the potential side effects?
Potential side effects may include discomfort from taking capsules and risks associated with introducing new bacteria into your body such as bloating, gas or changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and have had 3 or more C. difficile infections in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with an inflammatory bowel disease.
Select...
I cannot swallow pills.
Select...
I rely on nutrition through IV due to short gut syndrome.
Select...
I have had part or all of my stomach surgically removed.
Select...
I have an untreated intestinal parasite infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrent colitis due to Clostridium difficile
Secondary study objectives
Mortality
Rate of adverse events
Safety of oral fecal microbiota transplantation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: fecal microbiota transplantationExperimental Treatment1 Intervention
fecal microbiota transplantation

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,475 Total Patients Enrolled
Gary M Cox, MDPrincipal InvestigatorDuke University

Media Library

Fecal Microbiota (Fecal Microbiota Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT02127398 — Phase 2
Clostridium Difficile Colitis Research Study Groups: fecal microbiota transplantation
Clostridium Difficile Colitis Clinical Trial 2023: Fecal Microbiota Highlights & Side Effects. Trial Name: NCT02127398 — Phase 2
Fecal Microbiota (Fecal Microbiota Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02127398 — Phase 2
~11 spots leftby May 2026
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