Fecal Microbiota Transplantation in Pediatric Crohn's Disease
ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-16
SponsorBiao Zou
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Standardized FMT
Other interventionFecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Repeated and multiple FMTs plus PENExperimental treatment 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 8 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 4-8 weeks after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Biao Zou
Lead sponsor
Tongji Hospital
Sponsor institution
Source ClinicalTrials.gov