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

Primary Purpose

Crohn Disease

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

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring fecal microbiota transplantation , Crohn Disease

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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 and enema; unwilling to give informed consent/assent

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repeated and multiple FMTs plus PEN

Arm Description

repeated and multiple FMTs plus PEN(50% of total calories as polymeric diet, Peptamen, Nestle, Vevey, Switzerland) in refractory pediatric CD

Outcomes

Primary Outcome Measures

Clinical remission
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Endoscopic remission
Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2
Mucosal healing
Mucosal healing defined as SES-CD = 0

Secondary Outcome Measures

Adverse events
All possible adverse events:fever,abdominal pain,infectious diseases and others

Full Information

First Posted
April 4, 2022
Last Updated
October 10, 2023
Sponsor
Biao Zou
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1. Study Identification

Unique Protocol Identification Number
NCT05321745
Brief Title
Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Acronym
FMT
Official Title
Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (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

5. Study Description

Brief 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
fecal microbiota transplantation , Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Partial enteral nutrition,FMT
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repeated and multiple FMTs plus PEN
Arm Type
Experimental
Arm Description
repeated and multiple FMTs plus PEN(50% of total calories as polymeric diet, Peptamen, Nestle, Vevey, Switzerland) in refractory pediatric CD
Intervention Type
Other
Intervention Name(s)
Standardized FMT
Other Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Primary Outcome Measure Information:
Title
Clinical remission
Description
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Time Frame
8-12 weeks after FMT
Title
Endoscopic remission
Description
Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2
Time Frame
8-12 weeks after FMT
Title
Mucosal healing
Description
Mucosal healing defined as SES-CD = 0
Time Frame
8-12 weeks after FMT
Secondary Outcome Measure Information:
Title
Adverse events
Description
All possible adverse events:fever,abdominal pain,infectious diseases and others
Time Frame
2 and 8 weeks after FMT
Other Pre-specified Outcome Measures:
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 4-8 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biao Zou, doctor
Phone
027-83663594
Email
464021552@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sainan Shu, MD, PhD
Phone
027-83663594
Email
shusainan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sainan Shu, MD, PhD
Organizational Affiliation
Tongji Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biao Zou, doctor
Phone
15871365900
Email
464021552@qq.com
First Name & Middle Initial & Last Name & Degree
Sainan Shu, PhD
Phone
027-83663594
Email
shusainan@163.com

12. IPD Sharing Statement

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Fecal Microbiota Transplantation in Pediatric Crohn's Disease

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