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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
Stage 4 subjects having greater than 2 liters of stool per day and/or severe abdominal cramping, bleeding or ileus
Acute GvHD defined as experiencing GvHD symptoms starting prior to day +100 after HSCT
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have stage 4 and experience frequent loose stools, severe stomach pain, bleeding, or blockage in your intestines.
Select...
You have experienced symptoms of GvHD (graft-versus-host disease) within the first 100 days after a stem cell transplant.
Select...
You can easily and safely swallow capsules without any difficulty or discomfort.

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
359 Previous Clinical Trials
26,082 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

Frequently Asked Questions

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

Am I qualified to participate in this research endeavor?

"This clinical trial seeks 10 participants between adolescence and late adulthood that have graft versus host disease. To qualify, one must be refractory to steroid treatment or resistant after 5 days of systemic steroids (> 1 mg/kg/day methylprednisolone), capable of swallowing capsules without difficulty, and in stage 4 with greater than 2 liters of stool per day as well as intense abdominal pain, haemorrhage or ileus."

Answered by AI

Is there an opportunity for participants to join this research project?

"This clinical trial is no longer actively enrolling. It was first made available on September 1st 2023 and the information present was last altered more than a year ago, on September 16th 2022. Despite this study's closure, there are presently 171 other medical studies that need participants to be recruited."

Answered by AI

Does this clinical experiment extend to patients of an underage age?

"Potential patients must be aged between 18 and 80 to take part in this study. Alternatively, there are 65 trials for those under the age of majority and 147 studies available to persons above seniority."

Answered by AI

Has the Fecal Microbiota Transplantation Capsule received authorization from federal regulators?

"As this clinical trial is in its initial phase, Fecal Microbiota Transplantation Capsule has only limited research backing up its safety and efficacy. As such, we have assigned a score of 1 to it."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Fecal Microbiota Transplantation for the Treatment of Severe Acute Gut Graft-Versus-Host Disease
2023. "Fecal Microbiota Transplantation for the Treatment of Severe Acute Gut Graft-Versus-Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04280471.
~0 spots leftby Dec 2024
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