Phase
Condition
Inflammatory Bowel Disease
Crohn's Disease
Treatment
OpenBiome FMT product FMP250
MTP 101-LF
Clinical Study ID
Ages 10-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Aged >=10 to <=60 years.
Able to provide informed consent (for ages >=18 years) or has a parent or guardianwho can provide informed consent on their behalf (for ages <18 years).
Have confirmed prior diagnoses of CGD and CGD-AC (or CGD-IBD with evidence ofcolitis on colonoscopy).
Fecal calprotectin level >=200 microgram/g.
HBI score >=5 (to be evaluated on Day 1).
No planned change in systemic antibiotic regimen for CGD for 1 month preceding FMT.
No planned escalation in CGD-IBD treatment for 1 month preceding FMT.
If taking monoclonal antibodies for CGD-IBD, the dose must be stable for 12 weekswith no planned escalation.
Participants who can become pregnant must agree to use at least one highly effectivemethod of contraception when engaging in sexual activities that can result inpregnancy, starting at screening until the end of study participation. Highlyeffective methods include a barrier (eg, condom, diaphragm, cervical cap),intrauterine device, or hormonal contraception.
Exclusion
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Evidence of acute GI infection, including active GI abscesses.
Presence of C difficile toxin gene in stool, as identified by PCR, in screeningperiod.
History of intestinal obstruction definitively related to CGD-IBD.
History of fistulizing CGD-IBD or CGD-IBD intra-abdominal abscesses.
History of CGD-IBD related non-transversable intestinal strictures.
History of AEs attributable to previous FMT.
History of significant liver disease (eg, biopsy-proven nodular regenerativehyperplasia), including portal hypertension or cirrhosis.
Pregnant or breastfeeding.
History of severe food allergy.
Any contraindication to having colonoscopy under anesthesia.
Any condition that, in the opinion of the investigator, contraindicatesparticipation in this study.
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesActive - Recruiting
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