Status:
RECRUITING
Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
Lead Sponsor:
Mayo Clinic
Conditions:
Bile Acid Malabsorption
Bile Acid Diarrhea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
Detailed Description
In this placebo-controlled trial, the De Simone combination probiotic formulation will be tested in 12 patients in each treatment arm. The patient's will be previously diagnosed with bile acid diarrhe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06609148
Start Date
January 2 2025
End Date
March 30 2026
Last Update
October 14 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905