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

Crohn Disease Clinical Trial

— FMT  

Official title:

Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321758
• Other study ID #: 83663594
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Tongji Hospital
• Contact: Biao Zou, MD
• Phone: 15871365900
• Email: 464021552[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Biological:
• Fecal Microbiota Transplantation
In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.

Drug:
• Immunosuppressive Agents
hormones, azathioprine, thalidomide

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Clinical remission	Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score=10	8-12 weeks after FMT
Primary	Endoscopic remission	Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) = 2	8-12 weeks after FMT
Primary	Mucosal healing	Mucosal healing defined as SES-CD = 0	8-12 weeks after FMT
Secondary	Adverse events	All possible adverse events:fever,abdominal pain,infectious diseases and others	2 and 10 weeks after FMT