NCT06609148

Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption/Diarrhea Unassociated With Ileal Resection

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

In this placebo-controlled trial, the De Simone combination probiotic formulation will be tested in 12 patients in each treatment arm. The patient's will be previously diagnosed with bile acid diarrhea. The objective is to assess the effects of this probiotic on fecal blood low acid levels in patients with bile acid diarrhea. Secondary objectives are to evaluate changes in% primary fecal bile acids in a single stool sample, serum 7 alpha C4, intestinal permeability, stool consistency and frequency, fecal short chain fatty acids, and fecal micro biome composition and diversity

Conditions

• Bile Acid Malabsorption
• Bile Acid Diarrhea

Interventions

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

Timeline

• Start date: 2025-01-02
• Primary completion: 2025-12-31
• Completion: 2026-03-30
• First posted: 2024-09-24
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States