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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am over 18 and have had 3 or more C. difficile infections in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrent colitis due to Clostridium difficile
Secondary outcome measures
Mortality
Rate of adverse events
Rate of hospitalization
+3 moreTrial 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
2,363 Previous Clinical Trials
3,420,476 Total Patients Enrolled
Gary M Cox, MDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an inflammatory bowel disease.I cannot swallow pills.I am not on antibiotics for an infection other than C. difficile.You have a life expectancy of less than 180 days.I rely on nutrition through IV due to short gut syndrome.I have had part or all of my stomach surgically removed.I am over 18 and have had 3 or more C. difficile infections in the last year.I have an untreated intestinal parasite infection.I will not start chemotherapy within 2 weeks before or after fecal transplantation.
Research Study Groups:
This trial has the following groups:- Group 1: fecal microbiota transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential perils has fecal microbiota been linked to in patients?
"The safety rating of fecal microbiota was 2 due to clinical evidence indicating its security, though efficacy has yet to be established in any trials."
Answered by AI
Is enrollment currently open for this research endeavor?
"According to data on clinicaltrials.gov, this research project is currently in search of individuals who meet its requirements. It was originally posted on April 1st 2016 and the latest update occurred on September 26th 2022."
Answered by AI
How many participants have signed up for the experiment?
"Affirmative. Information on clinicaltrials.gov states that this investigation is presently seeking volunteers, with its initial posting occuring in April of 2016 and the latest amendment taking place during September 26th 2022. The research needs to recruit a total of 10 individuals from one trial site."
Answered by AI
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