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

NCT ID: NCT05321758

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-22
• Study Completion Date: 2027-06-30

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.

Detailed Description

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FMT group

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.

Group Type: ACTIVE_COMPARATOR

Fecal Microbiota Transplantation

Intervention Type: BIOLOGICAL

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

Immunosuppressive group

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

Group Type: SHAM_COMPARATOR

Immunosuppressive Agents

Intervention Type: DRUG

hormones, azathioprine, thalidomide

Interventions

Fecal Microbiota Transplantation

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

Intervention Type: BIOLOGICAL

Immunosuppressive Agents

hormones, azathioprine, thalidomide

Intervention Type: DRUG

Other Intervention Names

FMT; Immunosuppressive group

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Biao Zou

attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhihua Huang

Role: STUDY_DIRECTOR

Tongji Hospital

Locations

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Biao Zou, MD

Role: CONTACT

464021552@qq.com

15871365900

Sainan Shu, MD, PhD

Role: CONTACT

shusainan@163.com

13886011908

Facility Contacts

Biao Zou

Role: primary

464021552@qq.com

15871365900

Sainan Shu

Role: backup

shusainan@163.com

13886011908

References

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.

Reference Type: DERIVED

PMID: 40050917 (View on PubMed)

Other Identifiers

83663594

Identifier Type: -

Identifier Source: org_study_id