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Fecal Microbiota Transplantation in Pediatric Crohn's Disease

Recruiting
2 - 16 years of age
Both
Phase N/A

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Overview

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

Description

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 in the treatment of refractory pediatric CD. In the induction stage of CD, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 1-2 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course, and the withdrawal of conventional drug therapy was gradually reduced. Refractory CD was defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).

Eligibility

Inclusion Criteria:

        Aged 2-16 years and without genetic diseases; All refractory pediatric with
        mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity
        index (PCDAI) >10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) > 3 were enrolled in
        the study; refractory CD, defined by children who failed conventional treatment (hormone,
        immunosuppressant, biologics)
        Exclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less
        than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube
        insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal
        capsule; unwilling to give informed consent/assent

Study details

Crohn Disease

NCT05321745

Biao Zou

25 January 2024

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