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Poop pills? fecal transplants show promise for gut infections

NCT ID NCT04090346

Disease control Sponsor: Methodist Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested fecal microbiota transplant (FMT) in 24 adults with recurrent Clostridium difficile infection (C. diff) that didn't get better with standard antibiotics. FMT involves placing healthy donor stool into the patient's colon to restore good bacteria. The goal was to see if this treatment reduces the need for repeat transplants, surgery, or more antibiotics.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

24 people

The number who actually took part.

Started

Jun 2018

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Recurring CDI after three episodes of mild to moderate C Diff infections and failure to respond to appropriate antimicrobial treatment of six to eight weeks. * Metronidazole * Vancomycin * At least two episodes of severe C diff infection that have required hospitalization and significant morbidity within one year * Severe C Diff infection requiring hospitalization and non- responsive to maximal medication therapy Exclusion Criteria: * advanced Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) * cirrhosis of the liver * recent bone marrow transplants * medication suppressed immune systems (allowed per physician discretion if benefit outweighs risk) * pregnancy * Toxic megacolon or ileus present

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis Clostridium infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clostridium difficile infection

Contacts and locations

Locations

  • Methodist Mansfield Medical Center

    Dallas, Texas, 75203, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.