GVHDEarly Phase 1NCT05094765
Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD
A Early Phase 1 study testing FMT in people with GVHD, run by Shenzhen Xbiome Biotech Co., Ltd..
Trial summary
This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs. host disease after allogeneic stem cell transplantation Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- GVHD
- What is being tested?
- FMT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 2 Mar 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. GVHD within 100 days after allogeneic hematopoietic stem cell transplantation (allo HSCT);
- 2. Age 18 - 65 years old, regardless of gender;
- 3. Patients with grade 3 or 4 gastrointestinal involvement (aGVHD) according to the International Alliance (Magic) classification standard;
- 4. Patients with glucocorticoid resistant GI aGVHD are diagnosed. According to the expert consensus of Chinese allogeneic hematopoietic stem cell transplantation for the treatment of hematological diseases (III) - acute graft-versus-host disease (2020 Edition), the definition of glucocorticoid resistant acute GVHD is Thomas' hematopoietic cell transplantation: stem cell transplantation (5th Edition) Glucocorticoid resistance was defined as PD at 3 days, NR at 7 days or Cr not reached at 14 days after first-line treatment.
- 5. ECoG 3 points or less;
- 6. Stop prophylactic antibiotics at least 12 hours before FMT treatment;
- 7. Be able and willing to sign informed consent;
- 8. Patients who are capable of swallowing capsules and can complete the study;
Who cannot join
- 1. There are active but uncontrolled infections, except GVHD complicated with infectious diarrhea;
- 2. Gastrointestinal perforation, active gastrointestinal bleeding, small intestinal obstruction, toxic megacolon or other serious gastrointestinal diseases not caused by GVHD;
- 3. Have a history of severe allergic reaction; Or known to be allergic to any ingredient of intestinal bacteria capsule xbi-302;
- 4. Any serious disease that can increase the risk of patients participating in the study;
- 5. Female subjects with positive pregnancy test and lactation, or female subjects of childbearing age who refuse to take contraceptive measures during the study;
- 6. According to the judgment of the researcher, the patients with high dynamic diarrhea can not stay in the intestine for enough time to dissolve the capsule.
Show all 12Show fewer
- 7. HIV, HBV, HCV and syphilis are positive;
- 8. After colectomy;
- 9. Participate in other intervention clinical studies within 4 weeks before the screening period;
- 10. The expected survival time is less than 12 weeks;
- 11. The basic body function test is inferior to the following standards: total neutrophils (neu) < 0.5 (x109 / L), platelet count (PLT) < 30 (x109 / L), serum creatinine (CR) > 1.5 times the maximum normal value (ULN), albumin (ALB) < 25g / L;
- 12. There is any situation that the researcher thinks is not suitable for inclusion (any history of medical history, treatment history or abnormal test data that may confuse the results of this study, interfere with the subject's whole participation in the study, or harm the interests of the subject).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating Safety and Efficacy of GI-XBI-302 in Patients With Glucocorticoid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation
This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs. host disease after allogeneic stem cell transplantation
- Conditions
- GVHD
- Being tested
- FMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTBiological
Fecal Microbiota Transplantation
| Study group | Role | What they receive |
|---|---|---|
| FMT | Experimental | 60 capsules per day for 2 day Receives: Biological: FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
assessed by Overall Response Rate (ORR) at Day 28
Measured: Day 28
AE
assessed all related a grade 3 or above adverse event (AE) at Day 28
Measured: Day 28
Secondary outcomes (4)
AE
assessed all related adverse event (AE)
Measured: up to 25 weeks
Shannon index
changes of Shannon index
Measured: up to 25 weeks
colonization bacteria analysis
the number and relative abundance of bacteria that originally existed only in the capsule but could still be detected in the stool samples of subjects
Measured: up to 25 weeks
PFS
Kaplan-Meier Curve
Measured: up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion2 Mar 2023 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHDStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Xbiome Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094765
- Sponsor's protocol ID
- XCT4843002
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety and Efficacy of GI-XBI-302 in Patients With Glucocorticoid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05094765
- Acronym / sponsor ID
- XCT4843002
- Conditions
- GVHD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shenzhen Xbiome Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 26 Oct 2021 (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.
This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs. host disease after allogeneic stem cell transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT | Experimental | Biological: FMT60 capsules per day for 2 day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. GVHD within 100 days after allogeneic hematopoietic stem cell transplantation (allo HSCT);
- 2. Age 18 - 65 years old, regardless of gender;
- 3. Patients with grade 3 or 4 gastrointestinal involvement (aGVHD) according to the International Alliance (Magic) classification standard;
- 4. Patients with glucocorticoid resistant GI aGVHD are diagnosed. According to the expert consensus of Chinese allogeneic hematopoietic stem cell transplantation for the treatment of hematological diseases (III) - acute graft-versus-host disease (2020 Edition), the definition of glucocorticoid resistant acute GVHD is Thomas' hematopoietic cell transplantation: stem cell transplantation (5th Edition) Glucocorticoid resistance was defined as PD at 3 days, NR at 7 days or Cr not reached at 14 days after first-line treatment.
- 5. ECoG 3 points or less;
Key exclusion criteria (12 listed)
- 1. There are active but uncontrolled infections, except GVHD complicated with infectious diarrhea;
- 2. Gastrointestinal perforation, active gastrointestinal bleeding, small intestinal obstruction, toxic megacolon or other serious gastrointestinal diseases not caused by GVHD;
- 3. Have a history of severe allergic reaction; Or known to be allergic to any ingredient of intestinal bacteria capsule xbi-302;
- 4. Any serious disease that can increase the risk of patients participating in the study;
- 5. Female subjects with positive pregnancy test and lactation, or female subjects of childbearing age who refuse to take contraceptive measures during the study;
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 |
|---|---|---|
| FMTFecal Microbiota Transplantation | Biological | FMT |
Primary outcome
ORR
Time frame: Day 28
assessed by Overall Response Rate (ORR) at Day 28
AE
Time frame: Day 28
assessed all related a grade 3 or above adverse event (AE) at Day 28
4 secondary outcomes
AE
Time frame: up to 25 weeks
Shannon index
Time frame: up to 25 weeks
colonization bacteria analysis
Time frame: up to 25 weeks
PFS
Time frame: up to 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FMT in people with GVHD, run by Shenzhen Xbiome Biotech Co., Ltd..
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yanli zhao (0316-3306412, 13121053519@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Day 28). The study lists 2 primary outcomes in all. 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 26 Oct 2021.