Probiotic in Patients With Bile Acid Malabsorption/Diarrhea (NCT06609148) | Clinical Trial Compass
RecruitingNot Applicable
Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
United States24 participantsStarted 2025-01-02
Plain-language summary
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
Who can participate
Age range18 Years
SexALL
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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 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:
* Surgical sterilization
* Hormonal contraception (implantable, patch, oral, intra-muscular)
* Intra-uterine device
* Double barrier method (diaphragm plus condom)
* At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensure…