NCT05321758

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2020Jun 2027

Study Start

First participant enrolled

March 22, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

7.3 years

First QC Date

April 4, 2022

Last Update Submit

April 8, 2025

Conditions

Crohn Disease

Keywords

Crohn Disease;fecal microbiota transplantation

Outcome Measures

Primary Outcomes (3)

  • Clinical remission

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

    8-12 weeks after FMT

  • Endoscopic remission

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

    8-12 weeks after FMT

  • Mucosal healing

    Mucosal healing defined as SES-CD = 0

    8-12 weeks after FMT

Secondary Outcomes (1)

  • Adverse events

    2 and 10 weeks after FMT

Other Outcomes (1)

  • gut microbial

    before treatment and 5-10 weeks after treatment

Study Arms (2)

FMT group

ACTIVE COMPARATOR

Repeated and multiple FMTs plus PEN(80%) in the treatment of pediatric CD. Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) and FMT intervention. In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.

Biological: Fecal Microbiota Transplantation

Immunosuppressive group

SHAM COMPARATOR

Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) combined with Immunosuppressants (hormones, azathioprine, thalidomide) treatment.

Drug: Immunosuppressive Agents

Interventions

Fecal Microbiota TransplantationBIOLOGICAL

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

Also known as: FMT
FMT group
Immunosuppressive AgentsDRUG

hormones, azathioprine, thalidomide

Also known as: Immunosuppressive group
Immunosuppressive group

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

  • Zou B, Liu S, Dong C, Shen H, Lv Y, He J, Li X, Ruan M, Huang Z, Shu S. Fecal microbiota transplantation restores gut microbiota diversity in children with active Crohn's disease: a prospective trial. J Transl Med. 2025 Mar 6;23(1):288. doi: 10.1186/s12967-024-05832-1.

    PMID: 40050917DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Fecal Microbiota TransplantationImmunosuppressive Agents

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsImmunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Zhihua Huang

    Tongji Hospital

    STUDY DIRECTOR

Central Study Contacts

Biao Zou, MD

CONTACT

15871365900464021552@qq.com

Sainan Shu, MD, PhD

CONTACT

13886011908shusainan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Partial enteral nutrition,FMT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 11, 2022

Study Start

March 22, 2020

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)