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NCT Number: NCT05321758

Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

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.

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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 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.

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; 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

Treatment and study plan

Fecal microbiota transplantation

Biological

In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.

Other names: FMT

Immunosuppressive Agents

Drug

hormones, azathioprine, thalidomide

Other names: Immunosuppressive group

Primary outcomes

  1. Clinical remission

    Time frame: 8-12 weeks after FMT

    Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10

  2. Endoscopic remission

    Time frame: 8-12 weeks after FMT

    Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2

  3. Mucosal healing

    Time frame: 8-12 weeks after FMT

    Mucosal healing defined as SES-CD = 0

Secondary outcomes

  1. Adverse events

    Time frame: 2 and 10 weeks after FMT

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

Other outcomes

  1. gut microbial

    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.

Study contacts

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

Biao Zou, MD

CONTACT

[email protected]

15871365900

Sainan Shu, MD, PhD

CONTACT

[email protected]

13886011908

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease

Acronym: FMT

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 11, 2022
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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