Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

NCT05679622 | Recruiting

• 1 other identifier: 63639979
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

Fecal microbiota transplantation, Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• clinical response

  reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline

  8-12 weeks after FMT

• clinical remission

  Clinical remission defined as a PUCAI \<10

  8-12 weeks after FMT

• safety of FMT

  All possible adverse events: fever, abdominal pain, infectious diseases and others.

  8-12 weeks after FMT

Secondary Outcomes (7)

• Number of patients requiring escalation of medical therapies

  8-12 weeks after FMT

• Number of patients with endoscopic remission

  8-12 weeks after FMT

• Fecal calprotectin level

  8-12 weeks after FMT

• C-reactive protein levels

  8-12 weeks after FMT

• erythrocyte sedimentation rate (ESR) level

  8-12 weeks after FMT

Study Arms (1)

FMT group

EXPERIMENTAL

In the refractory ulcerative colitis group, our study is aims to explore repeated and multiple FMTs plus PEN in the treatment of refractory pediatric UC;

Other: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation OTHER

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.

FMT group

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age of older than 2 years and younger than 16 years with no genetic diseases; as a first-line treatment group for UC, newly diagnosed with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy

You may not qualify if:

• Children who were treated by PEN (80%) less than 8 weeks; As a first-line treatment group for UC, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment; 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

Sponsors & Collaborators

• Biao Zou: lead

Study Sites (1)

Tongji Hospital

Wuhan, 430030, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Zhihua Huang

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Biao Zou

CONTACT

+8685726753; 464021552@qq.com

Sainan Shu, MD, PhD

CONTACT

shusainan@163.com; shusainan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending physician, Pediatric Department

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: January 11, 2023
• Study Start: December 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)