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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 10Eligibility criteria met