Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
- Conditions
- Bile Acid MalabsorptionBile Acid Diarrhea
- Interventions
- Dietary Supplement: De Simone formulation probioticDietary Supplement: Placebo
- Registration Number
- NCT06609148
- Lead Sponsor
- Mayo Clinic
- Brief 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic Group De Simone formulation probiotic - Control Group Placebo -
- Primary Outcome Measures
Name Time Method Change in fecal bile acid concentration Baseline, 24 days Reported as micromoles per g stool and % primary bile acids
- Secondary Outcome Measures
Name Time Method Change in intestinal permeability Baseline, 24 days Intestinal permeability will be measured using the standardized, validated 13C-mannitol and lactulose urine excretion test and reported as a ratio of the percentage excretion of lactulose and mannitol in urine
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States