The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Subjects will be given De Simone formulation probiotic 900 billion CFU, 3 times per day for 21-24 days
Subjects will be given a placebo for 21-24 days
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGChange in fecal bile acid concentration
Reported as micromoles per g stool and % primary bile acids
Time frame: Baseline, 24 days
Change in intestinal permeability
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
Time frame: Baseline, 24 days
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