Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- De Simone formulation probiotic
- Placebo
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov