Acute Graft-Versus-Host DiseaseNCT07188909
Clinical Observation on the Efficacy of Patient-Donor Derived Probiotics in Improving Intestinal Flora Disorder in Patients With Intestinal Acute Graft-Versus-Host Disease (aGVHD)
A study testing Patient-Donor Derived Probiotics in people with Acute Graft-Versus-Host Disease, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Acute Graft-Versus-Host Disease
- What is being tested?
- Patient-Donor Derived Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 4 Mar 2026
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible for this study must satisfy all of the following criteria:
- Age >50 years, regardless of gender;
- Scheduled for haploidentical hematopoietic stem cell transplantation;
- ECOG performance status score ≤2;
- Voluntarily participate and provide written informed consent.
Who cannot join
- Subjects presenting with any of the following conditions will be excluded from this study:
- Active or chronic infectious diseases, including recent febrile symptoms (axillary temperature ≥37.3°C within 48h);
- Gastrointestinal disorders:
- Clostridioides difficile infection (CDI): Recurrent or refractory CDI;
- Other conditions: Ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS), diarrhea associated with dysbiosis, liver cirrhosis;
- Allergic or immune-mediated diseases:
- Autoimmune hepatitis, systemic lupus erythematosus (SLE), ankylosing spondylitis, immune-mediated osteoarthritis, allergic dermatitis, immune thrombocytopenic purpura (ITP);
- Antibiotic usage within 7 days prior to 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
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 300020
Erlie Jiang, +86 22 23608600, jiangerlie@ihcams.ac.cn
About this study
To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.
Read the detailed description
Study Design Overview:
Ten patients aged >50 years scheduled for haploidentical hematopoietic stem cell transplantation (HSCT) will be enrolled. Stool specimens will be collected from both patients and donors (due to frequent depletion of beneficial bacteria in such patients, donor specimens are essential to enhance probiotic detection and cultivation rates). Patient specimens will undergo 16S rDNA intestinal microbiome analysis.
Upon clinical diagnosis of intestinal aGVHD:
- Pre-collected patient and donor specimens will be homogenized
- Target isolation and culture of core beneficial bacteria (Lactobacillus and Bifidobacterium)
- Strain identification via TOF mass spectrometry
- Fermentation and preparation of 200 enteric-coated capsules (100 Lactobacillus capsules + 100 Bifidobacterium capsules)
Post-intervention assessment (100 days after administration):
Changes in microbiome composition, relative abundance, species diversity, biochemical indicators, and bowel movement characteristics will be evaluated to assess the therapeutic efficacy of patient/donor-derived Lactobacillus and Bifidobacterium in GVHD.
- Conditions
- Acute Graft-Versus-Host Disease
- Being tested
- Patient-Donor Derived Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Donor Derived ProbioticsDrug
To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Donor Derived Probiotics | Experimental | To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation. Receives: Drug: Patient-Donor Derived Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate of intestinal acute graft-versus-host disease (aGVHD)
Changes of stool frequency of subjects before and after taking probiotic capsules from patients.
Measured: within 100 days
Secondary outcomes (1)
To study the changes of intestinal flora of subjects before and after taking probiotics from patients for 100 days
16SrDNA intestinal flora detection, to study the changes of Bifidobacterium, Lactobacillus and Clostridium before and after taking probiotics from patients for 100 days.
Measured: within 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion4 Mar 2026 (estimated)
- Study completion4 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188909
- Sponsor's protocol ID
- IIT2025086
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 23 Sep 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation on the Efficacy of Patient-Donor Derived Probiotics in Improving Intestinal Flora Disorder in Patients With Intestinal Acute Graft-Versus-Host Disease (aGVHD)
- ClinicalTrials.gov ID
- NCT07188909
- Acronym / sponsor ID
- IIT2025086
- Conditions
- Acute Graft-Versus-Host Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 4 Mar 2026 (estimated)
- Study completion
- 4 Mar 2026 (estimated)
- First posted
- 23 Sep 2025 (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.
To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.
Detailed description
Study Design Overview:
Ten patients aged >50 years scheduled for haploidentical hematopoietic stem cell transplantation (HSCT) will be enrolled. Stool specimens will be collected from both patients and donors (due to frequent depletion of beneficial bacteria in such patients, donor specimens are essential to enhance probiotic detection and cultivation rates). Patient specimens will undergo 16S rDNA intestinal microbiome analysis.
Upon clinical diagnosis of intestinal aGVHD:
- Pre-collected patient and donor specimens will be homogenized
- Target isolation and culture of core beneficial bacteria (Lactobacillus and Bifidobacterium)
- Strain identification via TOF mass spectrometry
- Fermentation and preparation of 200 enteric-coated capsules (100 Lactobacillus capsules + 100 Bifidobacterium capsules)
Post-intervention assessment (100 days after administration):
Changes in microbiome composition, relative abundance, species diversity, biochemical indicators, and bowel movement characteristics will be evaluated to assess the therapeutic efficacy of patient/donor-derived Lactobacillus and Bifidobacterium in GVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient-Donor Derived Probiotics | Experimental | Drug: Patient-Donor Derived ProbioticsTo clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >50 years, regardless of gender;
- Scheduled for haploidentical hematopoietic stem cell transplantation;
- ECOG performance status score ≤2;
- Voluntarily participate and provide written informed consent.
Key exclusion criteria (8 listed)
- Subjects presenting with any of the following conditions will be excluded from this study:
- Active or chronic infectious diseases, including recent febrile symptoms (axillary temperature ≥37.3°C within 48h);
- Gastrointestinal disorders:
- Allergic or immune-mediated diseases:
- Autoimmune hepatitis, systemic lupus erythematosus (SLE), ankylosing spondylitis, immune-mediated osteoarthritis, allergic dermatitis, immune thrombocytopenic purpura (ITP);
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 |
|---|---|---|
| Patient-Donor Derived ProbioticsTo clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation. | Drug | Patient-Donor Derived Probiotics |
Primary outcome
Clinical response rate of intestinal acute graft-versus-host disease (aGVHD)
Time frame: within 100 days
Changes of stool frequency of subjects before and after taking probiotic capsules from patients.
1 secondary outcome
To study the changes of intestinal flora of subjects before and after taking probiotics from patients for 100 days
Time frame: within 100 days
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 23 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Donor Derived Probiotics in people with Acute Graft-Versus-Host Disease, run by Institute of Hematology & Blood Diseases Hospital, China 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Sep 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 Erlie Jiang, doctor (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate of intestinal acute graft-versus-host disease (aGVHD) (time frame: within 100 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 23 Sep 2025.