FMT in Transplant-related Gastrointestinal Mucositis | NCT07622849

Studies
FMT in Transplant-related Gastrointestinal Mucositis

NCT07622849

Sponsor

The First Affiliated Hospital of Soochow University

Status

Enrolling by invitation

Last Update Posted

Jun 3, 2026Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Transplant-related Gastrointestinal Mucositis

Interventions

Fecal Microbiota

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Dec 1, 2028Estimated

First Submitted Date

May 28, 2026

First Submission Date that Met QC Criteria

May 28, 2026

First Posted Date

Jun 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2026

Last Update Posted Date

Jun 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qi Xiao-Fei, professor, The First Affiliated Hospital of Soochow UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital of Soochow UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

With the stem cell transplant increasing, patients which effected with transplant-related gastrointestinal mucositis (TRGM) have also increased. To evaluate the safety and efficacy of FMT for TRGM, patients with TRGM were recruited.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Fecal Microbiota	Biological	fecal microbiota transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
aGVHD	Occurrence time and severity of aGVHD	2 weeks, 4 weeks, 2 months, 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Transplant-related gastrointestinal mucositis

Exclusion Criteria:

age>65; or age<15;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who suffered transplant-related gastrointestinal mucositis were recruited, and treated with FMT

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soochow University		Suzhou	Jiangsu	215006	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069467	Fecal Microbiota Transplantation

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided