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NCT Number: NCT05679622

Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

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

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Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

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; 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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. clinical response

    Time frame: 8-12 weeks after FMT

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

  2. clinical remission

    Time frame: 8-12 weeks after FMT

    Clinical remission defined as a PUCAI <10

  3. safety of FMT

    Time frame: 8-12 weeks after FMT

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

Secondary outcomes

  1. Number of patients requiring escalation of medical therapies

    Time frame: 8-12 weeks after FMT

    Number of patients requiring escalation of medical therapies based on clinical relapse. Clinical relapse is defined by requiring additional medical therapy.

  2. Number of patients with endoscopic remission

    Time frame: 8-12 weeks after FMT

    Number of patients with endoscopic remission as defined by a PUCAI score of 0

  3. Fecal calprotectin level

    Time frame: 8-12 weeks after FMT

    Mean change of Fecal calprotectin levels

  4. C-reactive protein levels

    Time frame: 8-12 weeks after FMT

    Mean change of C-reactive protein levels

  5. erythrocyte sedimentation rate (ESR) level

    Time frame: 8-12 weeks after FMT

    Mean change of erythrocyte sedimentation rate (ESR)

  6. The number of stools or bloody stools

    Time frame: 8-12 weeks after FMT

    Improvement in the number of stools or bloody stools

  7. gut microbial

    Time frame: before treatment and 4 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Biao Zou

CONTACT

[email protected]

+8685726753

Sainan Shu, MD, PhD

CONTACT

[email protected]

[email protected]

Sponsors and collaborators

Lead sponsor

Biao Zou

Other

Registry information

Official study title

Repeated and Multiple Fecal Microbiota Transplantations in Active Pediatric Ulcerative Colitis (UC)

Acronym: FMT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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