FMT in Pediatric Crohn's Disease (FMTPCD)
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|ClinicalTrials.gov Identifier: NCT03194529|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : March 13, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease Pediatric Crohns Disease||Biological: FMT||Phase 1 Phase 2|
The Investigators hypothesize that children with Crohn's disease who are in remission can receive a single endoscopic dose of FMT with no significant safety concerns.
All children will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy. Children will be seen at baseline, then 4 and 24 weeks after study drug administration begins. Stools will be collected and stored for gut microbial profiles during the study visit windows. In addition, a follow up telephone call will be performed 7 days after study drug is administered. If children undergo endoscopy as part of the standard of care, study staff will obtain 1-2 additional biopsies for evaluation of mucosal inflammation. This study will also capture any laboratory results if any of the subjects undergo laboratory testing as part of the standard of care. This study will define the effects of transplant on gut microbial profile using advanced molecular taxonomic approaches. Safety will be closely monitored by solicited (during defined telephone calls and study visits) and unsolicited adverse events (at all times). Safety will be the primary endpoint of this study. Secondary endpoints include Pediatric Crohn's Disease Activity Index (PCDAI), changes in gut microbial diversity - determined by gut microbial genomics and proteomics (16S ribosomal RNA, 16s rRNA), and outcome measures for mucosal inflammation and repair as reflected through laboratory testing such as the level for C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), inflammatory cytokines of the colonic mucosa as well as the stool calprotectin level.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Primary outcome is safety in children with Crohn's disease in remission.|
|Masking:||None (Open Label)|
|Official Title:||Safety of FMT in Maintenance of Pediatric Crohn's Disease|
|Actual Study Start Date :||October 9, 2017|
|Actual Primary Completion Date :||June 30, 2019|
|Actual Study Completion Date :||July 31, 2019|
Experimental: FMT in children with disease remission
All children (with Crohn's disease in remission) will receive the equivalent of 50 g of stools from a healthy donor (FMT) into the jejunum through upper endoscopy.
Fecal Microbiota Transplantation, single dose, 50g of stool, delivered via standard of care upper endoscopy into jejunum.
Other Name: Fecal Microbiota Transplantation
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 24 weeks ]Safety will be closely monitored (during defined telephone calls and study visits) and adverse events will be documented, including mucosal inflammation episodes and standard of care laboratory test abnormalities.
- Crohn's disease activity [ Time Frame: 24 weeks ]PCDAI scores will be collected
- Changes in gut microbiome [ Time Frame: 24 weeks ]The effects of transplant on the gut microbial profile will be determined using advanced molecular taxonomic approaches (gut microbial profiling).
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|Ages Eligible for Study:||7 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age: 7-21 who have been diagnosed with Crohn's disease
- Remission of disease defined as PCDAI <10
- Needs upper GI endoscopy
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194529
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Principal Investigator:||Sonia Michail, MD||Children's Hospital Los Angeles|
|Responsible Party:||Children's Hospital Los Angeles|
|Other Study ID Numbers:||
|First Posted:||June 21, 2017 Key Record Dates|
|Last Update Posted:||March 13, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Fecal Microbiota Transplantation
Inflammatory Bowel Diseases
Digestive System Diseases