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NCT Number: NCT05321745

Fecal Microbiota Transplantation in Pediatric Crohn's Disease

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

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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 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized FMT

Other

Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon

Other names: Fecal Microbiota Transplantation

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 8 weeks after FMT

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

Other outcomes

  1. gut microbial

    Time frame: before treatment and 4-8 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, doctor

CONTACT

[email protected]

027-83663594

Sainan Shu, MD, PhD

CONTACT

[email protected]

027-83663594

Sponsors and collaborators

Lead sponsor

Biao Zou

Other

Registry information

Official study title

Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease

Acronym: FMT

Important dates

Study start
2022
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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