Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
| Condition(s) | Bile Acid Malabsorption, Bile Acid Diarrhea |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM. |
| Who can participate | 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 spontan |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Mayo Clinic |
| Locations | Rochester, Minnesota, United States |
| Start date | 2025-01-02 |
| NCT ID | NCT06609148 |
| Official listing | https://clinicaltrials.gov/study/NCT06609148 |