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The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
Full 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
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Inclusion criteria
Prior diagnosis of bile acid malabsorption documented in the medical history based on
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 pregnancy test prior to dispensing the study product
Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study:
Exclusion criteria
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Allocation
Interventional model
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24 participants in 2 patient groups, including a placebo group
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Central trial contact
John Damianos, MD
Data sourced from clinicaltrials.gov
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