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Can swallowing healthy donor stool capsules stop recurrent c. diff?

NCT ID NCT02127398

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether capsules containing stool from healthy donors can treat recurrent Clostridium difficile colitis, a severe bowel infection that keeps coming back. Adults who have had three or more episodes in the past year may participate. Researchers give the capsules by mouth and follow participants for six months to see if the infection resolves without returning. The goal is to restore a healthy balance of bacteria in the gut.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fecal microbiota in capsule form
What this could lead to
If it works, this could offer a simple, non-invasive way to stop recurrent C. difficile infections, reducing the need for repeated antibiotics.
What could go wrong
This is a Phase 2 trial, so the approach is still being tested for safety and effectiveness. Some people may not respond, and there is a small risk of side effects from the capsules.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 77 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Apr 2016

Expected to finish

May 2027

An estimate. End dates often move.

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

18 years and older

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: * Study entry is open to adults (\>18 years old) who have had three of more episodes of Clostridium difficile colitis within the previous 12 months. Exclusion Criteria: * Absolute neutrophil count \< 500 cells/mm3 * Active infection at other sites (excluding Clostridium difficile) requiring ongoing antibacterial therapy (antiviral or antifungal therapy is acceptable) * Current or planned cytotoxic chemotherapy within 14 days of the potential fecal transplantation date * Life expectancy \<180 days * Diagnosis of inflammatory bowel disease (e.g. Crohn's or ulcerative colitis) * Inability to swallow capsules * Indwelling nasogastric, orogastric, gastrostomy, or jejunostomy tube * History of partial or total gastrectomy * Short gut syndrome requiring total parenteral nutrition * Pregnancy * Documented intestinal parasite infection without documentation of appropriate treatment

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Conditions

The condition(s) this trial relates to.

Clostridium difficile colitis

As listed by the trial registrant

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

Clostridium difficile colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States