Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

Inclusion criteria:

• Prior diagnosis of bile acid malabsorption documented in the medical history basedon

• 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 FormScale, 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 determineeligibility.

• 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 wholestudy: unless they meet the criteria of post-menopausal, i.e. 12 months ofspontaneous amenorrhea, women of child-bearing potential, defined as all womenphysiologically 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 contraceptionthat 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 incases where age, career, lifestyle, or sexual orientation of the patientensures compliance

Exclusion criteria:

• Use of oral antibiotics and probiotics within the last 4 weeks.

• Pregnancy or lactation.

• Concomitant use of bile acid sequestrants, must stop 10 days before starting 7-daystool dairy and for the duration of the study.

• History of ileal resection.

• Diabetes mellitus (type 1)

• BMI ≥ 40 kg/m^2

• Diagnosis of gastrointestinal diseases that are associated with inflammation such asinflammatory bowel diseases and celiac diseases or gastrointestinal infection in theprior 4 weeks

• Any condition or personal circumstance that, in the opinion of the investigator,renders the subject unlikely or unable to comply with the full study protocol orcould interfere with the study assessments