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Poop pills aim to stop gut from brewing alcohol

NCT ID NCT06083142

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether fecal microbiota transplant (FMT) capsules are safe and doable for people with auto-brewery syndrome, a rare condition where gut microbes turn carbs into alcohol. Eight adults will take antibiotics and a colon cleanse, then receive five FMT capsules over a week. They will be monitored for six months for side effects and changes in blood alcohol levels.

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Study facts

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

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 8 people

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

Started

Feb 2025

Expected to finish

Aug 2030

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: * 18-70 with documented ABS symptoms for at least one year, including supervised ethanol testing or a positive glucose challenge test in a supervised setting. * Active ABS including at least 3 flares by either serum or breath alcohol levels in the past year (blood or breath samples) * Subject's microbiome produces alcohol ex vivo in bioreactor (Schnabl laboratory) * Willing and able to travel to Boston for in person assessment (modest reimbursement available) * Willing to stop antifungals, and any other complimentary therapies for ABS, if taking * Medically able to withstand clean out. If participants are over 60, the subject must have previously tolerated a prior colonoscopic "prep" as part of prior routine care. * Local physician contact available Exclusion Criteria: * Unwilling/unable to swallow large capsules (e.g.esophageal stricture or hiatal hernia) * Delayed gastric emptying syndrome * Known chronic aspiration, or chronic nausea/vomiting * Pregnant (pregnancy testing will be performed in women of childbearing potential; women over 52 with no menses for 12 months will not require testing) * Patients with an acute active illness or acute exacerbation of underlying comorbid condition. * Patients on unstable, or increasing immunosuppressive agents including high dose corticosteroids(40 mg prednisone daily or more), calcineurin inhibitors, escalating immunosuppression for organ rejection, active chemotherapy with expected neutropenia, current or neutropenia (ANC \<1000) within the last year. * Patients with decompensated cirrhosis, advanced HIV/AIDS, recent bone marrow transplant, or other severe immunodeficiency. * Severe food allergy or intolerance (donors are omnivores and do not maintain dietary restrictions) * Cannot document at least 2 COVID vaccinations. Those refusing all COVID vaccination are not eligible for FMT. * Ulcerative colitis or Crohn's disease (microbiome manipulation may precipitate a flare of these illnesses). * Active HIV, hepatitis B or C infection (subjects with prior treated hepatitis C must have undetectable viral load; HIV positive subjects must be receiving anti-retroviral therapy with undetectable viral loads x 1 year minimum, Hepatitis B core antibody positive subjects are allowed if negative HepB surface antigen and antibody) * Taking warfarin (known to be affected by dietary and microbiome changes). NOACs do not exclude. * On suppressive antibacterial agents, or expected to receive prophylactic antibacterials within the year, for example a patient with a prosthetic heart valve who routinely receives dental prophylaxis, or patient with chronic UTIs anticipated to need treatment frequently * Known biliary structural abnormalities. * Allergy to erythromycin, neomycin, or rifaximin. * Type I diabetes mellitus * History of pancreatitis or biliary sepsis

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States