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Microbiota Therapy

Fecal Microbiota Transplantation for Graft-versus-Host Disease

Q: What potential hazards should be taken into consideration when considering Group I (fecal microbiota transplant) treatment?

<p>Our team gave Group I (fecal microbiota <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a>) a score of 2 on the safety scale due to prior Phase 2 trial data suggesting it is inoffensive, though efficacy has not yet been established.</p>

Phase 2

Recruiting

Led By Armin Rashidi

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade III-IV acute GVHD

Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months post-hct

Awards & highlights

Study Summary

This trial tests whether a fecal transplant can help prevent a complication of hematopoietic cell transplants: severe acute graft-vs-host disease. Fecal transplant can help restore a healthy gut microbiota after transplant.

Who is the study for?

Adults undergoing allogeneic hematopoietic cell transplantation for blood cancers can join this trial. They must be able to swallow capsules, not pregnant or breastfeeding, willing to use contraception, and have no severe food allergies or chronic aspiration. Participants should not be on other experimental GVHD prevention agents.Check my eligibility

What is being tested?

The study is testing if swallowing fecal microbiota transplantation capsules can prevent severe acute graft versus host disease after a transplant. Half the participants will receive these capsules and half will get a placebo, chosen randomly.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort or changes in bowel habits due to the introduction of new gut bacteria from the fecal transplant capsules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not had severe acute graft-versus-host disease.

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I am scheduled for a stem cell transplant from a donor.

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I am taking tacrolimus or cyclosporine and MMF.

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My donor is almost or fully matched to me.

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All my side effects, except for low red blood cells and platelets, are mild.

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I am not taking any antibiotics, except for preventing PCP as part of my standard care.

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I am taking Sirolimus, Cyclosporine, and MMF.

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I am receiving a specific post-transplant treatment regimen.

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I am taking tacrolimus or cyclosporine with methotrexate.

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I am 18 years old or older.

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I have a sibling donor who is an HLA match.

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My donor is a half-match for my transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months post-hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months post-hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months post-hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Grade III-IV acute graft versus host disease (GVHD)

Secondary outcome measures

Chronic GVHD

Clostridium difficile diarrhea

Grade II-IV acute GVHD

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group I (fecal microbiota transplant)Experimental Treatment1 Intervention

Patients receive fecal microbiota capsules PO QD for 7 days

Group II: Group II (Placebo)Placebo Group1 Intervention

Patients receive placebo PO QD for 7 days

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor

557 Previous Clinical Trials

1,343,377 Total Patients Enrolled

1 Trials studying Graft-versus-Host Disease

10 Patients Enrolled for Graft-versus-Host Disease

Armin RashidiPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being sought for this trial?

"According to information provided on clinicaltrials.gov, this medical trial is not presently accepting patients for enrollment. The initial post date was January 1st 2024 and the recency of updates stopped on September 6th 2023; nevertheless, there are still 187 other trials that have open slots for participants."

Answered by AI

What potential hazards should be taken into consideration when considering Group I (fecal microbiota transplant) treatment?

"Our team gave Group I (fecal microbiota transplant) a score of 2 on the safety scale due to prior Phase 2 trial data suggesting it is inoffensive, though efficacy has not yet been established."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

2023. "Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06026371.

All > Graft Vs Host Disease