Fecal Microbiota Transplantation in Pediatric Crohn's Disease (FMT)

Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory 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

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Standardized FMT

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 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).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Biao Zou, doctor; Phone Number: 027-83663594; Email: 464021552@qq.com
• Study Contact Backup: Name: Sainan Shu, MD, PhD; Phone Number: 027-83663594; Email: shusainan@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Biao Zou, doctor; Phone Number: 15871365900; Email: 464021552@qq.com
      • Contact: Sainan Shu, PhD; Phone Number: 027-83663594; Email: shusainan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repeated and multiple FMTs plus PEN; repeated and multiple FMTs plus PEN(50% of total calories as polymeric diet, Peptamen, Nestle, Vevey, Switzerland) in refractory pediatric CD	Other: Standardized FMT; Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon; Other Names: Fecal Microbiota Transplantation

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 8 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 4-8 weeks after treatment

Collaborators and Investigators

• Sponsor: Biao Zou
• Investigators: Study Director: Sainan Shu, MD, PhD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: fecal microbiota transplantation , Crohn Disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: TJ-IRB20220127 (Other Identifier: Tongji Hospital)

Drug and device information, study documents

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