Tongji Hospital
Wuhan, Hubei, 430030, China
Location status: Recruiting
NCT Number: NCT05321758
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.
Interested in participating?
Request Info2 year–16 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430030, China
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of >10 and ≤40, and SES-CD of >3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy
Exclusion criteria
patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.
Other names: FMT
hormones, azathioprine, thalidomide
Other names: Immunosuppressive group
Time frame: 8-12 weeks after FMT
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Time frame: 8-12 weeks after FMT
Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2
Time frame: 8-12 weeks after FMT
Mucosal healing defined as SES-CD = 0
Time frame: 2 and 10 weeks after FMT
All possible adverse events:fever,abdominal pain,infectious diseases and others
Time frame: before treatment and 5-10 weeks after treatment
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.
Contact information is provided by the study sponsor or research team.
Biao Zou, MD
CONTACT
Sainan Shu, MD, PhD
CONTACT
Tongji Hospital
Other
Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease
Acronym: FMT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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