This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC
Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of UC, and that FMT could be a useful treatment. In the refractory ulcerative colitis group, our study is aims to explore FMT plus PEN in the treatment of refractory pediatric UC. In the induction stage of UC, standard therapy remained unchanged, FMT and PEN treatment are added, and the investigators hope the withdrawal of conventional drug therapy was gradually reduced. Refractory UC is defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents). As a first-line treatment group for UC, our study is aims to explore FMT plus PEN as a first-line treatment for active UC in children. participants treated with FMT coupled with PEN are defined as the FMT group, and those treated with PEN coupled with mesalazine served as the PEN group. FMT treatment is given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval. All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT group are given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval. All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.
Tongji Hospital
Wuhan, China
RECRUITINGclinical response
reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline
Time frame: 8-12 weeks after FMT
clinical remission
Clinical remission defined as a PUCAI \<10
Time frame: 8-12 weeks after FMT
safety of FMT
All possible adverse events: fever, abdominal pain, infectious diseases and others.
Time frame: 8-12 weeks after FMT
Number of patients requiring escalation of medical therapies
Number of patients requiring escalation of medical therapies based on clinical relapse. Clinical relapse is defined by requiring additional medical therapy.
Time frame: 8-12 weeks after FMT
Number of patients with endoscopic remission
Number of patients with endoscopic remission as defined by a PUCAI score of 0
Time frame: 8-12 weeks after FMT
Fecal calprotectin level
Mean change of Fecal calprotectin levels
Time frame: 8-12 weeks after FMT
C-reactive protein levels
Mean change of C-reactive protein levels
Time frame: 8-12 weeks after FMT
erythrocyte sedimentation rate (ESR) level
Mean change of erythrocyte sedimentation rate (ESR)
Time frame: 8-12 weeks after FMT
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The number of stools or bloody stools
Improvement in the number of stools or bloody stools
Time frame: 8-12 weeks after FMT
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 weeks after treatment