NCT07622849

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
28mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Mar 2023Dec 2028

Study Start

First participant enrolled

March 1, 2023

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

5.8 years

First QC Date

May 28, 2026

Last Update Submit

May 28, 2026

Conditions

Transplant-related Gastrointestinal Mucositis

Outcome Measures

Primary Outcomes (1)

  • aGVHD

    Occurrence time and severity of aGVHD

    2 weeks, 4 weeks, 2 months, 3 months

Interventions

Fecal MicrobiotaBIOLOGICAL

fecal microbiota transplantation

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Transplant-related gastrointestinal mucositis

You may not qualify if:

  • age\>65; or age\<15;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 3, 2026

Study Start

March 1, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)