Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

Ulcerative Colitis Clinical Trial

— FMT  

Official title:

Repeated and Multiple Fecal Microbiota Transplantations in Active Pediatric Ulcerative Colitis (UC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679622
• Other study ID #: 63639979
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Tongji Hospital
• Contact: Biao Zou
• Phone: +8685726753
• Email: 464021552[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC

Description:

Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of UC, and that FMT could be a useful treatment. In the refractory ulcerative colitis group, our study is aims to explore FMT plus PEN in the treatment of refractory pediatric UC. In the induction stage of UC, standard therapy remained unchanged, FMT and PEN treatment are added, and the investigators hope the withdrawal of conventional drug therapy was gradually reduced. Refractory UC is defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).

As a first-line treatment group for UC, our study is aims to explore FMT plus PEN as a first-line treatment for active UC in children. participants treated with FMT coupled with PEN are defined as the FMT group, and those treated with PEN coupled with mesalazine served as the PEN group.

FMT treatment is given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval.

All the participants 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: 30
• 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; as a first-line treatment group for UC, newly diagnosed with mild-to-moderate UC (defined by the PUCAI of >10 and=64); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PUCAI of >10 and=64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy

Exclusion Criteria:

Children who were treated by PEN (80%) less than 8 weeks; As a first-line treatment group for UC, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment; 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

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Fecal Microbiota Transplantation
In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT group are given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval. All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Biao Zou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response	reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) =30% from baseline	8-12 weeks after FMT
Primary	clinical remission	Clinical remission defined as a PUCAI <10	8-12 weeks after FMT
Primary	safety of FMT	All possible adverse events: fever, abdominal pain, infectious diseases and others.	8-12 weeks after FMT
Secondary	Number of patients requiring escalation of medical therapies	Number of patients requiring escalation of medical therapies based on clinical relapse. Clinical relapse is defined by requiring additional medical therapy.	8-12 weeks after FMT
Secondary	Number of patients with endoscopic remission	Number of patients with endoscopic remission as defined by a PUCAI score of 0	8-12 weeks after FMT
Secondary	Fecal calprotectin level	Mean change of Fecal calprotectin levels	8-12 weeks after FMT
Secondary	C-reactive protein levels	Mean change of C-reactive protein levels	8-12 weeks after FMT
Secondary	erythrocyte sedimentation rate (ESR) level	Mean change of erythrocyte sedimentation rate (ESR)	8-12 weeks after FMT
Secondary	The number of stools or bloody stools	Improvement in the number of stools or bloody stools	8-12 weeks after FMT
Secondary	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 weeks after treatment