NCT04660487

Brief Summary

With the stem cell transplanting increasing, patients which effected with "GVHD" were also increased. To evaluation the relationship between "FODMAPs" and "GVHD", Bone marrow transplant patients were recruited.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress91%
Dec 2020Dec 2026

Study Start

First participant enrolled

December 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

December 3, 2020

Last Update Submit

December 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occurrence of GVHD

    The occurrence time and degree of GVHD

    90 days

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Successful bone marrow colonization after bone marrow transplantation

You may qualify if:

  • Clinical diagnosis of "AML","ALL","MDS" or "MM" Disease;
  • Must be treated with bone marrow transplantation;
  • The transplanted bone marrow was successfully planted

You may not qualify if:

  • Gastrointestinal diseases;
  • Age\>60; or Age\<10;
  • Probiotics or prebiotics were taken before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

中国

Suzhou, Jiangsu, 215006, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

intestinal flora

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Depei Wu

    SOOCHOW UNIV

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 9, 2020

Study Start

December 1, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations