Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

Launched by MAYO CLINIC · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a specific probiotic called DSF on patients who have bile acid malabsorption (BAM), a condition that can cause diarrhea. The main goal is to see how this probiotic affects the levels of bile acids in the stool of participants. If you or a family member have been diagnosed with BAM and experience frequent loose stools, this study could be a way to find out if the probiotic can help improve your symptoms.

To join the study, participants should be between the ages of 65 and 74 and have a documented diagnosis of bile acid malabsorption. They will need to keep a 7-day diary of their stool consistency and may need to meet certain medical criteria related to their stool and blood tests. Women who can become pregnant must have a negative pregnancy test and agree to use contraception during the study. It’s important to note that individuals who have used antibiotics or probiotics in the last four weeks, are pregnant or breastfeeding, or have certain gastrointestinal conditions may not be eligible. Participants will be monitored throughout the study to see how the probiotic affects their condition.

Gender

ALL

Eligibility criteria

• 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 ensures 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-day stool 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 as inflammatory bowel diseases and celiac diseases or gastrointestinal infection in the prior 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 or could interfere with the study assessments