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

Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition 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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation; Drug: Immunosuppressive Agents

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Biao Zou, MD; Phone Number: 15871365900; Email: 464021552@qq.com
• Study Contact Backup: Name: Sainan Shu, MD, PhD; Phone Number: 13886011908; Email: shusainan@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Biao Zou; Phone Number: 15871365900; Email: 464021552@qq.com
      • Contact: Sainan Shu; Phone Number: 13886011908; Email: shusainan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Biological: Fecal Microbiota Transplantation; In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.; Other Names: FMT
Sham Comparator: 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.	Drug: Immunosuppressive Agents; hormones, azathioprine, thalidomide; Other Names: Immunosuppressive group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	All possible adverse events:fever,abdominal pain,infectious diseases and others	2 and 10 weeks after FMT

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
gut microbial	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.	before treatment and 5-10 weeks after treatment

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Study Director: Zhihua Huang, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Crohn Disease;fecal microbiota transplantation
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Immunologic Factors; Physiological Effects of Drugs; Immunosuppressive Agents
• Other Study ID Numbers: 83663594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No