Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-16
SponsorTongji Hospital
About this trial
To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Fecal Microbiota Transplantation
Biological/VaccineIn the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.
Immunosuppressive Agents
Drughormones, azathioprine, thalidomide
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: FMT groupActive comparator 1 intervention
Group B: Immunosuppressive groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical remission
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Time frame
8-12 weeks after FMT2
Endoscopic remission
Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
Time frame
8-12 weeks after FMT3
Mucosal healing
Mucosal healing defined as SES-CD = 0
Time frame
8-12 weeks after FMTSecondary outcomes
1
Adverse events
All possible adverse events:fever,abdominal pain,infectious diseases and others
Time frame
2 and 10 weeks after FMTOther outcomes
1
gut microbial
Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.
Time frame
before treatment and 5-10 weeks after treatmentSponsors and contacts
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Source ClinicalTrials.gov