Defined Fecal Microbiota Transplantation for Clostridium Difficile Diarrhea

Plain-language summary

This study evaluates fecal microbiota transplantation (FMT) for diarrhea from Clostridium difficile infection (CDI) that did not respond to, or relapsed after, standard antibiotics (metronidazole or vancomycin). It enrolls patients with confirmed treatment-resistant/relapsing CDI. It is a Phase 1 study enrolling by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Enrolling by invitation

Sponsor

Baylor College of Medicine

Intervention

Microbiota Transplantation (FMT)

Start date

2/28/2013

Estimated completion

2/28/2036

Countries

United States

Related genes

Locations

• Houston, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

Only VA patients will be eligible for the study if they have had a confirmed diagnosis of CDI that has been treated for 10-14 days with recommended doses of metronidazole or vancomycin and has either failed to respond, or has responded and relapsed within 4 weeks of the end of treatment. The diagnosis will be regarded as confirmed by the presence of diarrhea (\>3 unformed stools in a 24-hour period for 2 successive days) and abdominal discomfort. The presence of fever, leukocytosis, and a serum albumin \<3 gm/dL will be recorded but will not be necessary for the diagnosis. Patients will be included after they have given informed consent and signed the appropriate consent form that has been approved by the Baylor IRB.

Exclusion Criteria:

Exclusion criteria include: treatment with major immunosuppressive agents including prednisone \>10 mg/day (or its equivalent), calcineurin inhibitors, mammalian target of rapamycin (mTOR) inhibitors, lymphocyte-depleting biological agents, anti-tumor necrosis factor agents, and others; chemotherapeutic antineoplastic agents; decompensated liver cirrhosis; serum creatinine \>4 or need for hemodialysis; presence of an active malignancy other than superifical skin cancer (eg, basal cell); HIV/acquired immune deficiency syndrome; recent bone marrow transplant, or other cause of severe immunodeficiency; requirement for concurrent antimicrobial therapy; contraindication for ultra-slim endoscopy including severe chronic heart or lung disease; a chronic bedridden state; and any other condition suggesting that life span will not be \>1 yr.

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