Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption/Diarrhea Unassociated With Ileal Resection
Mayo Clinic
Summary
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 pr…
Interventions
- Dietary SupplementDe Simone formulation probiotic
Subjects will be given De Simone formulation probiotic 900 billion CFU, 3 times per day for 21-24 days
- Dietary SupplementPlacebo
Subjects will be given a placebo for 21-24 days
Location
- Mayo Clinic in RochesterRochester, Minnesota