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Microbiota Transplantation

Fecal Microbiota Transplantation for Clostridioides difficile Colitis

Phase 1
Waitlist Available
Led By David Y Graham, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
VA patients with confirmed diagnosis of CDI treated with metronidazole or vancomycin
Diagnosis confirmed by presence of diarrhea and abdominal discomfort
Must not have
Decompensated liver cirrhosis
Chemotherapeutic antineoplastic agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial is to confirm and extend the work of Trede and Rask-Madsen that administration of a defined fecal microbiota will lead to rapid and sustained resolution of C. difficile associated chronic relapsing diarrhea.

Who is the study for?
This trial is for VA patients with confirmed C. difficile infection (CDI) that persists or returns after standard treatment. They must be able to give informed consent and not have severe kidney issues, active serious cancer, HIV/AIDS, be bedridden, on high-dose steroids or other strong immune-suppressing drugs, have advanced liver disease, need certain concurrent antibiotics, or have a life expectancy under one year.Check my eligibility
What is being tested?
The study tests fecal microbiota transplantation (FMT), which involves transferring stool from a healthy donor to the patient's intestine to restore normal gut bacteria balance. This could suppress C. difficile growth and alleviate chronic diarrhea associated with CDI.See study design
What are the potential side effects?
In the limited number of patients treated so far in this study there were no adverse events reported post-FMT. Generally speaking though FMT can sometimes cause temporary digestive discomfort such as bloating and gas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a veteran diagnosed with CDI and treated with metronidazole or vancomycin.
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I have been diagnosed with a condition causing diarrhea and abdominal discomfort.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver is severely damaged and cannot function properly.
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I am currently taking or have taken chemotherapy drugs.
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I have HIV/AIDS.
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I recently had a bone marrow transplant or have a severe immune system problem.
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My kidney function is severely impaired.
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I am currently taking strong medications to suppress my immune system.
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I have an active cancer that is not just on the skin's surface.
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I am unable to get out of bed by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Binomial: success defined as resolution or no resolution of disease. Resolution is defined as either complete cessation of clinical symptoms or diagnostic confirmation of the absence of disease, during the period of follow-up after transplantation.

Trial Design

1Treatment groups
Experimental Treatment
Group I: microbiota transplantationExperimental Treatment1 Intervention
Two hundred mL of the bacterial suspension (microbiota transplantation) will be instilled into the small intestine via a catheter introduced through the biopsy channel of the endoscope and the flushed with 25 mL of sterile pre-reduced 0.9% saline. After removal of the endoscope, after recovery, patients will be allowed to resume a normal diet and physical activities.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,006 Previous Clinical Trials
6,003,296 Total Patients Enrolled
Michael E. DeBakey VA Medical CenterFED
64 Previous Clinical Trials
15,776 Total Patients Enrolled
Antone R Opekun, MS, PA-CStudy DirectorBaylor College of Medicine

Media Library

Defined Fecal Microbiota Transplantation (Microbiota Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT01868373 — Phase 1
Clostridioides difficile Colitis Research Study Groups: microbiota transplantation
Clostridioides difficile Colitis Clinical Trial 2023: Defined Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT01868373 — Phase 1
Defined Fecal Microbiota Transplantation (Microbiota Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01868373 — Phase 1
~6 spots leftby Feb 2035
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