Could a probiotic ease chronic diarrhea? mayo clinic investigates
NCT ID NCT06609148
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
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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
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24 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Jun 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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