Probiotic treatment for bile acid malabsorption and diarrhea
Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption/Diarrhea Unassociated With Ileal Resection
This study is testing whether a specific probiotic can help people with bile acid diarrhea by improving their stool consistency and reducing how often they go to the bathroom.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06609148 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of the De Simone formulation probiotic on fecal bile acid levels in patients diagnosed with bile acid diarrhea. It is a placebo-controlled trial involving 12 patients in each treatment arm, aiming to assess various outcomes including stool consistency, frequency, and microbiome composition. The study will also measure serum 7 alpha C4 levels and intestinal permeability to understand the probiotic's impact on bile acid malabsorption.
Who should consider this trial
Good fit: Ideal candidates are individuals with a documented diagnosis of bile acid malabsorption and diarrhea.
Not a fit: Patients without a confirmed diagnosis of bile acid malabsorption or those with other gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from bile acid malabsorption and diarrhea.
How similar studies have performed: While the use of probiotics in gastrointestinal disorders is a growing field, this specific approach targeting bile acid malabsorption is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michael Camilleri, MD, DSc — Mayo Clinic
- Study coordinator: John Damianos, MD
- Email: damianos.john@mayo.edu
- Phone: 5072842511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.