Transplant-related Gastrointestinal MucositisNCT07622849
FMT in Transplant-related Gastrointestinal Mucositis
An observational study of Transplant-related Gastrointestinal Mucositis, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplant-related Gastrointestinal Mucositis
- What is being tested?
- Fecal Microbiota
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Dec 2028
- How long will I take part?
- 12 Months
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who suffered transplant-related gastrointestinal mucositis were recruited, and treated with FMT
Who may be able to join
- Transplant-related gastrointestinal mucositis
Who cannot join
- age>65; or age<15;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: FMT in Transplant-related Gastrointestinal Mucositis Treatment
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.
- Being tested
- Fecal Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal MicrobiotaBiological
fecal microbiota transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
aGVHD
Occurrence time and severity of aGVHD
Measured: 2 weeks, 4 weeks, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Mar 2023
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant-related Gastrointestinal MucositisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Xiao-Fei, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622849
- Sponsor's protocol ID
- FMTTRGM20230001
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FMT in Transplant-related Gastrointestinal Mucositis Treatment
- ClinicalTrials.gov ID
- NCT07622849
- Acronym / sponsor ID
- FMTTRGM20230001
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 3 Jun 2026 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who suffered transplant-related gastrointestinal mucositis were recruited, and treated with FMT
Key inclusion criteria (1 listed)
- Transplant-related gastrointestinal mucositis
Key exclusion criteria (1 listed)
- age>65; or age<15;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiotafecal microbiota transplantation | Biological | – |
Primary outcome
aGVHD
Time frame: 2 weeks, 4 weeks, 2 months, 3 months
Occurrence time and severity of aGVHD
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transplant-related Gastrointestinal Mucositis, 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 3 Jun 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aGVHD (time frame: 2 weeks, 4 weeks, 2 months, 3 months). 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 3 Jun 2026.