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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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
443 Previous Clinical Trials
5,305,461 Total Patients Enrolled
Gabriela Maron, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
2,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant or nursing.I had a stem cell transplant from a donor more than 30 days ago.I have been diagnosed with gastroparesis by a GI specialist.My gut condition improved with high-dose steroids but worsened when the dose was reduced.I need a feeding tube.I am currently receiving radiation therapy to my abdomen.I am younger than 22 years old.My gut symptoms didn't improve after 5 days of high-dose steroid treatment.I have needed IV fluids or nutrition for more than 4 weeks.I am at high risk for abdominal infection due to devices inside me, dialysis, or fluid buildup.I have had a fecal microbiota transplant in the past.I have been diagnosed with a specific condition.I have had diarrhea or loose stools for more than 4 weeks.I have not had surgery in my belly area in the last 4 weeks.I don't have any health conditions or take medications that would make the study risky for me.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum A
- Group 2: Stratum B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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