Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a probiotic ease chronic diarrhea? mayo clinic investigates

NCT ID NCT06609148

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 2 times

Summary

This study tests whether a high-dose probiotic (De Simone formulation) can lower bile acid levels in stool and improve diarrhea in people with bile acid malabsorption. Twenty-four adults will take the probiotic or a placebo for about three weeks. Researchers will measure changes in stool bile acids and gut barrier function.

What this could mean

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

Active substance
De Simone formulation probiotic (dietary supplement)
What this could lead to
If it works, this could point toward a simple probiotic treatment to reduce diarrhea in people with bile acid malabsorption.
What could go wrong
This is a very small, early-phase trial with only 24 people. The probiotic may not change bile acid levels or symptoms, and results may not apply to everyone with the condition.

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

24 people

The number who actually took part.

Started

Jan 2025

Finished

Jun 2026

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: * Prior diagnosis of bile acid malabsorption documented in the medical history based on * either serum C4 \>52.5ng/mL, or * fecal 48h total BA excretion \>2337 μmol/48h, or * primary BA \>5% 48h stool collection or \>10% in single stool sample. * 7-day stool dairy with an average stool consistency based on the Bristol Stool Form Scale, BSFS, with a grade greater than 5. Note: If Inclusion criteria 3 is not met, participants may choose to have their blood drawn clinically to further determine eligibility. * For women of childbearing potential * A negative urine pregnancy test prior to dispensing the study product * Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study: * Surgical sterilization * Hormonal contraception (implantable, patch, oral, intra-muscular) * Intra-uterine device * Double barrier method (diaphragm plus condom) * At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance Exclusion criteria: * Use of oral antibiotics and probiotics within the last 4 weeks. * Pregnancy or lactation. * Concomitant use of bile acid sequestrants, must stop 10 days before starting 7-day stool dairy and for the duration of the study. * History of ileal resection. * Diabetes mellitus (type 1) * BMI ≥ 40 kg/m\^2 * Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac diseases or gastrointestinal infection in the prior 4 weeks * Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol or could interfere with the study assessments

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bile acid diarrhea are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

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