Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

Inclusion Criteria12

• 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.
• 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 ensures compliance