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Microbiota Restoration
Fecal Microbiota Transplantation Capsule for Gastrointestinal Tract Graft Versus Host Disease (GvHD)
Phase 1
Waitlist Available
Led By Grace Aldrovandi
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial is studying the side effects of using an investigational procedure, fecal microbiota transplantation, in treating patients with severe acute gut graft-versus-host-disease.
Eligible Conditions
- Severe Gastrointestinal Tract Acute Graft Versus Host Disease (GvHD)
- Graft-versus-Host Disease
- Gastrointestinal Tract Graft Versus Host Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Collection of stool, oral swabs and blood specimens to define bacterial taxa diversity, microbial translocation as well as metabolomic and proteomic changes associated with the development of graft versus host disease (GvHD)
GvHD improvement
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (OpenBiome FMT capsule DE)Experimental Treatment1 Intervention
Patients ingest OpenBiome FMT Capsule Dose Extended (DE) orally for two consecutive days. One dose is equivalent to the ingestion of 30 capsules and thus each day the patient will ingest 15 capsules. If no response is noted after 7 days, patients may receive a second dose of FMT for an additional 2 days.
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Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
361 Previous Clinical Trials
27,748 Total Patients Enrolled
Grace AldrovandiPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can easily and safely swallow capsules without any difficulty or discomfort.You have a blockage in your intestines or a condition called toxic megacolon.You have a history of severe food allergies.You have a condition called delayed gastric emptying syndrome, which means your stomach takes longer than usual to empty its contents.You have allergies to certain ingredients found in the study medication, such as sodium chloride, glycerol, or gelatin.You are currently taking experimental medications for the treatment of gut GvHD.You have experienced symptoms of GvHD (graft-versus-host disease) within the first 100 days after a stem cell transplant.You are currently experiencing bleeding in your stomach or intestines.You have a condition where you frequently inhale food or liquid into your lungs.You have a history of inflammatory bowel disease like Crohn's disease or ulcerative colitis.Your blood pressure or heart rate is not stable.You have trouble swallowing because of problems with your throat or muscles, such as from a stroke or conditions like multiple sclerosis or ALS.You have stage 4 and experience frequent loose stools, severe stomach pain, bleeding, or blockage in your intestines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (OpenBiome FMT capsule DE)
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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