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.
Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN as a first-line treatment for active Crohn's disease (CD) in children. The patients were divided into 2 groups voluntarily. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN combined with Immunosuppressants (hormones, azathioprine, thalidomide) served as the Immunosuppressive group. The therapeutic effect of the two groups was compared. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 1-3 courses, 3-6 times per course. The transplantation routes include oral capsule, enema and/or colonoscopy. All the patients 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.
hormones, azathioprine, thalidomide
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGClinical remission
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Time frame: 8-12 weeks after FMT
Endoscopic remission
Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2
Time frame: 8-12 weeks after FMT
Mucosal healing
Mucosal healing defined as SES-CD = 0
Time frame: 8-12 weeks after FMT
Adverse events
All possible adverse events:fever,abdominal pain,infectious diseases and others
Time frame: 2 and 10 weeks after FMT
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