Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD (NCT05094765) | Clinical Trial Compass
UnknownEarly Phase 1
Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD
15 participantsStarted 2021-11-01
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.