• 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 ensures compliance