FMT in Pediatric Crohn's Disease
Completed · Phase 1/Phase 2
Conditions studied: Crohn Disease, Pediatric Crohns Disease
In brief
The goal of this study is to evaluate the safety of Fecal Microbiota Transplantation (FMT) in children with Crohn's disease who are in remission. Safety will be the primary endpoint and Pediatric Crohn's Disease. Pediatric Crohn's Disease Activity Index (PCDAI) with other secondary endpoints including changes in gut microbial diversity will also be studied. All children will receive the equivalent of 50g of stools from a healthy donor into the jejunum through upper endoscopy. Also, 1-2 additional mucosal biopsies will be collected during patient's routine (standard of care) endoscopy. Subjects will have a total of 5 study visits within 24 weeks including phone call follow up on Day 7 after FMT.
Key facts
- Study ID
- NCT03194529
- Run by
- Children's Hospital Los Angeles
- People needed
- 9
- Starts
- 2017-10-09
- Expected to finish
- 2019-07-31
- Last updated by the study team
- 2020-03-13
Who can join
Age: 7 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age: 7-21 who have been diagnosed with Crohn's disease
- Remission of disease defined as PCDAI <10
- Needs upper GI endoscopy
You may not qualify if…
- Unwilling to give informed consent/assent
- Pregnancy and breast feeding in patient subjects of childbearing potential
- Subjects with significant renal and liver dysfunction (creatinine > 2 mg/dl and direct bilirubin > 2 mg/dl)
- Subjects with congenital or acquired immunodeficiency, or who are immunosuppressed due to conditions other than Crohn's disease (such as neoplastic disease or organ transplantation), have received or are receiving chemotherapy, or have been diagnosed with HIV.
- Subjects with severe food allergies
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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