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Microbiota Therapy

Fecal Microbiota Transplantation for Gastrointestinal Disorders After HCT

Phase 1
Waitlist Available
Led By Gabriela Maron, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
-- Requiring TPN or IVF for more than 4 weeks
- Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial studies if FMT is safe and effective for treating GI symptoms after HCT.

Who is the study for?
This trial is for children under 22 who've had a bone marrow transplant at least 30 days ago and are now having serious gut problems that steroids can't fix or keep coming back when trying to stop steroid treatment. They shouldn't be pregnant, have had previous FMT, recent belly surgery, devices in their abdomen (except certain feeding tubes), or be on dialysis.Check my eligibility
What is being tested?
The study tests if putting healthy stool from donors into the child's intestines is safe and could work for treating stubborn gut issues after a bone marrow transplant. It looks at how well kids handle this treatment and if it helps with their symptoms.See study design
What are the potential side effects?
Possible side effects of fecal transplants include stomach pain, bloating, diarrhea or constipation, fever, infection risk due to bacteria in the stool sample used for transplantation. The exact side effects can vary based on individual reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have needed IV fluids or nutrition for more than 4 weeks.
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My gut condition improved with high-dose steroids but worsened when the dose was reduced.
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I am younger than 22 years old.
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I need a feeding tube.
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I have had diarrhea or loose stools for more than 4 weeks.
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I had a stem cell transplant from a donor more than 30 days ago.
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I have been diagnosed with gastroparesis by a GI specialist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants providing all protocol required stool samples
Proportion of participants that drop up post-enrollment
Proportion of participants with a non-serious adverse event occurring within 30 days following FMT
+3 more
Secondary outcome measures
Percentage of participants who reduce or discontinue steroids at the end of the study
Proportion of participants with a complete response or a partial response

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stratum BExperimental Treatment1 Intervention
GI Dysfunction
Group II: Stratum AExperimental Treatment1 Intervention
Diagnosed with GvHD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal microbiota transplant (FMT)
2015
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
426 Previous Clinical Trials
5,306,585 Total Patients Enrolled
Gabriela Maron, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
2,000 Total Patients Enrolled

Media Library

Fecal microbiota transplant (FMT) (Microbiota Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05664113 — Phase 1
Gastrointestinal Disorder Research Study Groups: Stratum B, Stratum A
Gastrointestinal Disorder Clinical Trial 2023: Fecal microbiota transplant (FMT) Highlights & Side Effects. Trial Name: NCT05664113 — Phase 1
Fecal microbiota transplant (FMT) (Microbiota Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664113 — Phase 1

Frequently Asked Questions

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

Has Stratum A obtained FDA sanction?

"Considering the limited clinical data available to support safety and efficacy, Stratum A received a rating of 1 on our internal scale."

Answered by AI

Is enrollment for this research currently open to volunteers?

"Clinicaltrials.gov shows that this experiment is no longer recruiting, having last been updated on December 15th 2022. Despite the fact that it has stopped taking in new patients, there are 182 other trials presently open to participants."

Answered by AI
~13 spots leftby Dec 2024