Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

Part of paid clinical trials in Rochester, Minnesota.

Sponsor: Mayo Clinic
Study ID: NCT06609148
Status: Recruiting

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Conditions

Bile Acid Diarrhea
Bile Acid Malabsorption

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

De Simone formulation probiotic — DIETARY_SUPPLEMENT
Subjects will be given De Simone formulation probiotic 900 billion CFU, 3 times per day for 21-24 days
Placebo — DIETARY_SUPPLEMENT
Subjects will be given a placebo for 21-24 days

Study Details

The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.

Key Dates

Start date: Jan 2, 2025
Status verified: May 2026
Primary completion: Mar 31, 2026
Completion: Jun 30, 2026

Study Design

Enrollment: 24 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Probiotic Group
Placebo Comparator: Control Group

Primary Outcome Measure

Change in fecal bile acid concentration [ Time Frame: Baseline, 24 days ]

Central Contacts

John Damianos, MD
5072842511
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Mayo Clinic in Rochester	Rochester	Minnesota	55905	Michael Camilleri (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN