Fecal Microbiota Transplantation in Pediatric Crohn's Disease

Crohn Disease Clinical Trial

— FMT  

Official title:

Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321745
• Other study ID #: TJ-IRB20220127
• Secondary ID: TJ-IRB20220127
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: October 2023
• Source: Tongji Hospital
• Contact: Biao Zou, doctor
• Phone: 027-83663594
• Email: 464021552[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• Standardized FMT
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Biao Zou

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 4-8 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 8 weeks after FMT