FMT and Other Gut Microbial Therapies National Registry: Acute Severe and Fulminant C. Difficile Infection

Study on Gut Microbial Treatments for Severe C. Difficile Infection

Primary Investigator
M
Monika Fischer, MD

Primary Investigator

Enrolling By Invitation
17 years or below
All
Phase N/A
50 participants needed
1 Location

Brief description of study

The overarching goal of the registry is to expand knowledge and optimize practice in the transplantation of fecal microbiota or other gut microbial products. The objectives of this protocol regarding FMT for patients with acute severe/fulminant CDI include the following:
 
• Establishing the effectiveness, safety, and optimal method of administration of FMT using donor stool or other GMTs in hospitalized patients with acute severe or fulminant CDI.
• Characterize the impact of FMT and other GMTs on the resistome in hospitalized patients treated for acute severe or fulminant CDI.
• Determine the impact of FMT and other GMTs on the virome and mycobiome via analysis of SMS data.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects receiving FMT or other GMTs for a diagnosis of acute severe or fulminant CDI will be invited to join this registry. A formal medical history is completed bedside.

Detailed description of study

This FMT and Other Gut Microbial Therapeutics National Registry, formally the Fecal Microbiota Transplantation National Registry, will continue to prospectively enroll patients who undergo FMT
or other GMTs at sites throughout North America. The Registry’s title was changed to be more inclusive and more accurately reflect the collection of all gut-related microbial therapies. Select
sites reporting higher volume of hospitalized patients being treated for acute severe or fulminant CDI will participate in this protocol. Information on FMT/GMT methodology employed (e.g.,
screening of donor and recipient, preparation, FMT or other GMT delivery) will be collected from each site. Baseline information on recipients will also be collected. Specimens will be obtained from donor material and a stool sample will be obtained from recipients pre- and post-FMT or other GMTs. Following FMT or other GMT, patients will be followed daily until 5 days after final FMT or other GMT, then weekly during hospitalization and on day of discharge. This will include data on clinical status, diagnostic findings and outcomes.

Follow-up
information will be obtained at 1 month, 6 months, 1 year, and 2 years after FMT or other GMT. Data may be collected at a later timepoint up to 10 years post FMT. Follow-up information collected
will be used to assess short-term and long-term safety and effectiveness. Modifications to the current FMT Registry data-entry portal will be made related to treatment of patients with severe/fulminant CDI.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Fulminant C. Difficile Infection, Riley
  • Age: 17 years or below
  • Gender: All

Recipient Inclusion Criteria
• Hospitalized patients receiving FMT or other GMT for treatment of acute severe or fulminant C. difficile infection.
• Willingness to comply with biospecimen collection.

Known Donor Inclusion
• Providing stool sample for FMT

Subject Exclusion Criteria
• Incarceration

This study investigates the use of fecal microbiota transplantation (FMT) and other gut microbial therapies (GMT) for patients with severe Clostridioides difficile infection (CDI). The purpose is to understand how these treatments affect hospitalized patients with severe or fulminant CDI. Clostridioides difficile infection is a serious condition that can cause severe diarrhea and more serious intestinal conditions. FMT involves transplanting stool from a healthy donor to a patient to help restore healthy bacteria in the gut.

Participants will undergo FMT or other GMTs, and their progress will be monitored. The study will collect information on the methods used for FMT and GMT, such as donor screening and preparation. Participants will provide stool samples before and after treatment to help researchers study the effects of the therapies. Follow-up will occur daily during the initial treatment period, weekly during hospitalization, and at various intervals up to 10 years to assess the long-term safety and effectiveness of the treatments.

  • Who can participate: Hospitalized patients who are receiving FMT or other GMTs for treating acute severe or fulminant C. difficile infection can participate. Participants must be willing to comply with biospecimen collection. Incarcerated individuals cannot participate.
  • Study details: Participants will have FMT or other GMTs and provide stool samples before and after treatment. They will be monitored daily during the initial treatment and regularly thereafter. An inactive substance that looks like the investigational medicine/vaccine but does not contain any medicine is not used in this study.
Updated on 07 Aug 2026. Study ID: 25627
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only