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Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC) (FMT)

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
Biao Zou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Fecal microbiota transplantation, Ulcerative Colitis

Eligibility Criteria

2 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT group

Arm Description

In the refractory ulcerative colitis group, our study is aims to explore repeated and multiple FMTs plus PEN in the treatment of refractory pediatric UC;

Outcomes

Primary Outcome Measures

clinical response
reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline
clinical remission
Clinical remission defined as a PUCAI <10
safety of FMT
All possible adverse events: fever, abdominal pain, infectious diseases and others.

Secondary Outcome Measures

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.
Number of patients with endoscopic remission
Number of patients with endoscopic remission as defined by a PUCAI score of 0
Fecal calprotectin level
Mean change of Fecal calprotectin levels
C-reactive protein levels
Mean change of C-reactive protein levels
erythrocyte sedimentation rate (ESR) level
Mean change of erythrocyte sedimentation rate (ESR)
The number of stools or bloody stools
Improvement in the number of stools or bloody stools
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.

Full Information

First Posted
December 25, 2022
Last Updated
October 11, 2023
Sponsor
Biao Zou
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1. Study Identification

Unique Protocol Identification Number
NCT05679622
Brief Title
Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)
Acronym
FMT
Official Title
Repeated and Multiple Fecal Microbiota Transplantations in Active Pediatric Ulcerative Colitis (UC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Biao Zou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Fecal microbiota transplantation, Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT group
Arm Type
Experimental
Arm Description
In the refractory ulcerative colitis group, our study is aims to explore repeated and multiple FMTs plus PEN in the treatment of refractory pediatric UC;
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical response
Description
reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline
Time Frame
8-12 weeks after FMT
Title
clinical remission
Description
Clinical remission defined as a PUCAI <10
Time Frame
8-12 weeks after FMT
Title
safety of FMT
Description
All possible adverse events: fever, abdominal pain, infectious diseases and others.
Time Frame
8-12 weeks after FMT
Secondary Outcome Measure Information:
Title
Number of patients requiring escalation of medical therapies
Description
Number of patients requiring escalation of medical therapies based on clinical relapse. Clinical relapse is defined by requiring additional medical therapy.
Time Frame
8-12 weeks after FMT
Title
Number of patients with endoscopic remission
Description
Number of patients with endoscopic remission as defined by a PUCAI score of 0
Time Frame
8-12 weeks after FMT
Title
Fecal calprotectin level
Description
Mean change of Fecal calprotectin levels
Time Frame
8-12 weeks after FMT
Title
C-reactive protein levels
Description
Mean change of C-reactive protein levels
Time Frame
8-12 weeks after FMT
Title
erythrocyte sedimentation rate (ESR) level
Description
Mean change of erythrocyte sedimentation rate (ESR)
Time Frame
8-12 weeks after FMT
Title
The number of stools or bloody stools
Description
Improvement in the number of stools or bloody stools
Time Frame
8-12 weeks after FMT
Title
gut microbial
Description
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.
Time Frame
before treatment and 4 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biao Zou
Phone
+8685726753
Email
464021552@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sainan Shu, MD, PhD
Phone
shusainan@163.com
Email
shusainan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihua Huang
Organizational Affiliation
Tongji Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sainan Shu, professor
Phone
13886011908
Email
shusainan@163.com
First Name & Middle Initial & Last Name & Degree
Biao Zou
Phone
+8685726753
Email
464021552@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

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