NCT06609148 · Mayo Clinic
Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
What this study is about
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
View original scientific description
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
Interventions
DIETARY_SUPPLEMENT
De Simone formulation probiotic
Subjects will be given De Simone formulation probiotic 900 billion CFU, 3 times per day for 21-24 days
DIETARY_SUPPLEMENT
Placebo
Subjects will be given a placebo for 21-24 days
Primary outcome measures
Change in fecal bile acid concentration
Time frame: Baseline, 24 days
Reported as micromoles per g stool and % primary bile acids
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Rochester, Minnesota
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations