WithdrawnPhase 1

Fecal Microbiota Transplantation for the Treatment of Severe Acute Gut Graft-Versus-Host Disease

Stopped: The study was not opened

United States0Started 2023-09-01

Plain-language summary

This phase I trial studies the side effects of using an investigational procedure (fecal microbiota transplantation \[FMT\]) in treating patients with severe acute gut graft-versus-host-disease. The purpose of a fecal microbiota transplantation is to use feces from a healthy human donor to replace the abnormal gut bacteria in the recipient. One of the side effects of a stem cell transplant is the development of graft-versus-host disease (GvHD) in several organs including gut. GvHD is caused by the donated bone marrow or peripheral blood cells recognizing the recipient's body as foreign and attacking it. Acute gut GvHD is one of the leading causes of death after transplant. Recently, studies have shown that patients with reduced intestinal bacterial diversity in their stool during acute gut GvHD have higher overall mortality rates. The information learned from this study may offer FMT as a promising therapy for the treatment of severe acute gut graft-versus-host-disease.

Who can participate

Age range

18 Years – 80 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: * Subjects who received an allogenic hematopoietic stem cell transplantation (HSCT) * Acute GvHD defined as experiencing GvHD symptoms starting prior to day +100 after HSCT * Gut GvHD defined as subjects experiencing GvHD symptoms consistent with stage 3 or stage 4 by Center for International Blood and Marrow Transplant Research (CIBMTR) staging: * Stage 3 acute gut GvHD subjects having 1500-1999 mL stool per day * Stage 4 subjects having greater than 2 liters of stool per day and/or severe abdominal cramping, bleeding or ileus * Steroid-refractory acute gut GVHD defined as progression of symptoms after 3 days of systemic steroids (\> 1 mg/kg/day methylprednisolone) or steroid-resistant acute gut GvHD defined stable symptoms after 5 days of systemic steroids (\> 1 mg/kg/day methylprednisolone) * Able to swallow capsules without aspiration or dysphagia * Ability to understand the written informed consent and the willingness to sign the consent and accept the risk of receiving unrelated donor stool Exclusion Criteria: * Absolute neutrophil count \< 500 cells/uL * Presence of recurrent Clostridium difficile infection * Presence of ileus or toxic megacolon * History of multi-drug resistant stool pathogen * History of inflammatory bowel disease (i.e Crohn's disease or ulcerative colitis) * Uncontrolled and active systemic infection from bacteria, virus or fungus * Human immunodeficiency virus (HIV)-positive subjects * Quantifiable cytomegalovirus (CMV) …

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.

What they're measuring

Incidence of adverse events

Timeframe: Up to 6 months

Trial details

NCT IDNCT04280471

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Acute Graft Versus Host Disease trials