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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

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

NCT ID

NCT05321745

First Posted

April 4, 2022

Last Updated

October 10, 2023

Sponsor

Biao Zou

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

Studies a U.S. FDA-regulated Device Product

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

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

464021552@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sainan Shu, MD, PhD

Phone

027-83663594

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

464021552@qq.com

First Name & Middle Initial & Last Name & Degree

Sainan Shu, PhD

Phone

027-83663594

shusainan@163.com

12. IPD Sharing Statement

Learn more about this trial

Fecal Microbiota Transplantation in Pediatric Crohn's Disease

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