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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 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

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.

Find a Location

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

Fecal Microbiota Transplantation Capsule (Microbiota Restoration) Clinical Trial Eligibility Overview. Trial Name: NCT04280471 — Phase 1
Gastrointestinal Tract Graft Versus Host Disease (GvHD) Research Study Groups: Treatment (OpenBiome FMT capsule DE)
Gastrointestinal Tract Graft Versus Host Disease (GvHD) Clinical Trial 2023: Fecal Microbiota Transplantation Capsule Highlights & Side Effects. Trial Name: NCT04280471 — Phase 1
Fecal Microbiota Transplantation Capsule (Microbiota Restoration) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04280471 — Phase 1
~0 spots leftby Dec 2024