Actively Recruiting
MTC Versus FMT in for RCDI
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-11-10
60
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Investigating four different treatment of MTC or FMT
CONDITIONS
Official Title
MTC Versus FMT in for RCDI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Able and willing to provide written informed consent
- History of 2 episodes of recurrent CDI within the previous 6 months (including current episode)
- History of diarrhea with 3 or more unformed stools per day for 2 or more consecutive days consistent with CDI
- Positive stool test for toxigenic C. difficile within 60 days before randomization
- Completed a course of standard CDI antibiotics for 10 to 42 days with adequate clinical response (3 or fewer unformed stools per day for 2 or more consecutive days)
- CDI symptoms started within 60 days before randomization
You will not qualify if you...
- Female subjects who are pregnant, breastfeeding, or planning pregnancy during the study
- Women with reproductive potential not using reliable birth control methods
- Known or suspected toxic megacolon, ileus, or bowel obstruction at enrollment
- Active gastroenteritis from non-CDI infections
- Allergies to ingredients in the investigational product
- Prior participation in live biotherapeutic or FMT studies within 6 months
- Major gastrointestinal surgery within 3 months before enrollment
- Use of drugs altering gut motility
- History of acute leukemia, stem cell transplant, or myelosuppressive chemotherapy within 2 months
- Unable or unwilling to undergo colonoscopy
- Currently inpatient (must be outpatient for colonoscopy)
- Planned surgery within 30 days
- Need for ongoing non-CDI antibiotics
- History of total proctocolectomy
- Unable to provide informed consent
- Participation in other clinical trials within 30 days or simultaneously
- Severe food allergy causing anaphylaxis
- Life expectancy less than 6 months
- Unable to follow protocol requirements
- Received FMT in the past year
- Any condition deemed unsafe by investigators
- Clinically significant abnormal lab values or acute kidney injury
- Heavily immunosuppressed and negative for CMV or EBV
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
Sari Feldman, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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