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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
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 moreAwards & 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
2,462 Previous Clinical Trials
2,964,283 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.