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Poop pills vs. pancreatitis: can gut transplants stop deadly infections?

NCT ID NCT07153809

Disease control Sponsor: Changhai Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether transplanting healthy gut bacteria (FMT) can reduce infections in people with moderate to severe acute pancreatitis. 80 participants will receive either FMT or a placebo through a feeding tube for five days. The goal is to see if FMT lowers the risk of serious complications like infected pancreatic tissue or sepsis.

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 transplantation (FMT) bacterial solution
What this could lead to
If it works, this could offer a new way to prevent serious infections in people with acute pancreatitis.
What could go wrong
This is an early-stage trial with only 80 people, so results may not apply to everyone. FMT carries a small risk of introducing harmful bacteria.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

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

Started

Oct 2024

Expected to finish

Dec 2026

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 to 70 years

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: Age: 18-70 years old Diagnosis: Meets the diagnostic criteria for severe acute pancreatitis (SAP) * Organ function: There may be organ failure and systemic complications that can be recovered within 48 hours * Stage of the disease: Approximately 2 weeks after onset (non acute phase), accompanied by accumulation of pancreatic fluid volume, and significant improvement in CTSI score compared to before (grade II) * Nutritional support: Enteral nutrition tube has been left in place Feasibility of transplantation: No absolute contraindications for gut microbiota transplantation * Informed Consent: Voluntarily sign a written informed consent form * Gastrointestinal status: Abdominal pressure (bladder pressure measurement)\<12mmHg ◦ Existence of spontaneous defecation/exhaust Significant improvement in abdominal distension compared to before Exclusion Criteria: Serious complications: combined gastrointestinal bleeding or intestinal fistula * Special population: Pregnant or lactating women * Informed refusal: Failure to sign informed consent form * Basic organ dysfunction: Prior to admission, there were chronic organ dysfunction in the heart, lungs, liver, kidneys, or blood system Malignant tumor: Suffering from incurable malignant tumors * Immune abnormalities: Autoimmune diseases ◦ Immunosuppression status (solid organ/bone marrow transplantation history, AIDS, long-term use of immunosuppressants/hormones) * Enteral nutrition intolerance: unable to meet 50% of calorie requirements due to severe diarrhea, fibrotic intestinal stenosis, severe gastrointestinal edema, high flow intestinal fistula, etc * Systemic infection: meets the diagnostic criteria for systemic inflammatory response syndrome (SIRS) * Antibiotic dependence: broad-spectrum antibiotic intervention is required for combined extraintestinal organ infections * Immunodeficiency: Congenital or acquired immunodeficiency * Mental illness: severe mental disorders

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Conditions

The condition(s) this trial relates to.

acute necrotizing pancreatitis acute pancreatitis pancreatitis

As listed by the trial registrant

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

Acute pancreatitis Severe acute pancreatitis

How to take part

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

  1. The places running it

    2 sites. 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

  • Changhai Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Changhai Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

More trials for these conditions

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