Fecal Microbiota Transplantation in Pediatric Crohn's Disease
FMT
Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease
1 other identifier
interventional
40
1 country
1
Brief Summary
This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2022
CompletedFirst Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
November 4, 2024
November 1, 2024
4.2 years
April 4, 2022
November 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Clinical remission
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
8-12 weeks after FMT
Endoscopic remission
Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
8-12 weeks after FMT
Mucosal healing
Mucosal healing defined as SES-CD = 0
8-12 weeks after FMT
Secondary Outcomes (1)
Adverse events
2 and 8 weeks after FMT
Other Outcomes (1)
gut microbial
before treatment and 4-8 weeks after treatment
Study Arms (1)
Repeated and multiple FMTs plus PEN
EXPERIMENTALrepeated and multiple FMTs plus PEN(50% of total calories as polymeric diet, Peptamen, Nestle, Vevey, Switzerland) in refractory pediatric CD
Interventions
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Eligibility Criteria
You may qualify if:
- Aged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) \>10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) \> 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biao Zoulead
Study Sites (1)
Tongji Hospital
Wuhan, Hubei, 430030, China
Related Publications (1)
Zou B, Liu S, Dong C, Shen H, Lv Y, He J, Li X, Ruan M, Huang Z, Shu S. Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trial. J Transl Med. 2025 Mar 6;23(1):288. doi: 10.1186/s12967-024-05832-1.
PMID: 40050917DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sainan Shu, MD, PhD
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- attending physician
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 11, 2022
Study Start
March 22, 2022
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
November 4, 2024
Record last verified: 2024-11