Graft Versus Host DiseaseNCT04660487
Relationship Between "FODMAPs" and "GVHD"
An observational study of Graft Versus Host Disease, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Graft Versus Host Disease
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Successful bone marrow colonization after bone marrow transplantation
Who may be able to join
- Clinical diagnosis of "AML","ALL","MDS" or "MM" Disease;
- Must be treated with bone marrow transplantation;
- The transplanted bone marrow was successfully planted
Who cannot join
- Gastrointestinal diseases；
- Age>60; or Age<10；
- Probiotics or prebiotics were taken before enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
中国
Suzhou, Jiangsu, 215006
xiaofei qi, 051265223637, qixiaofei@suda.edu.cn
About this study
Official title: Relationship Between the Utilization and Degradation Rate of "FODMAPs" by Intestinal Flora and "GVHD"
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.
Read the detailed description
The feces were collected from the patients who had been successfully transplanted after bone marrow transplantation. After 24 hours of culture in the culture medium, the degradation rate of "FODMAPs" was detected, and the relationship between the degradation rate and the occurrence time and degree of "GVHD" was observed
- Conditions
- Graft Versus Host Disease
- Medical subject headings
- Graft vs Host Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of GVHD
The occurrence time and degree of GVHD
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Xiao-Fei, The First Affiliated Hospital of Soochow University
- Investigators
- Depei Wu, Study chair, SOOCHOW UNIV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660487
- Sponsor's protocol ID
- FODMAPS202001
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2020
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Utilization and Degradation Rate of "FODMAPs" by Intestinal Flora and "GVHD"
- ClinicalTrials.gov ID
- NCT04660487
- Acronym / sponsor ID
- FODMAPS202001
- Conditions
- Graft Versus Host Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The feces were collected from the patients who had been successfully transplanted after bone marrow transplantation. After 24 hours of culture in the culture medium, the degradation rate of "FODMAPs" was detected, and the relationship between the degradation rate and the occurrence time and degree of "GVHD" was observed
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Successful bone marrow colonization after bone marrow transplantation
Key inclusion criteria (3 listed)
- Clinical diagnosis of "AML","ALL","MDS" or "MM" Disease;
- Must be treated with bone marrow transplantation;
- The transplanted bone marrow was successfully planted
Key exclusion criteria (3 listed)
- Gastrointestinal diseases；
- Age>60; or Age<10；
- Probiotics or prebiotics were taken before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of GVHD
Time frame: 90 days
The occurrence time and degree of GVHD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Depei Wu study chair
SOOCHOW UNIV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Versus Host Disease, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaofei qi (+13812616208, qixf-sz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of GVHD (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.