Bile Acid MalabsorptionNCT06609148
Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
A study testing De Simone formulation probiotic in people with Bile Acid Malabsorption and Bile Acid Diarrhea, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Acid Malabsorption, Bile Acid Diarrhea
- What is being tested?
- De Simone formulation probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption/Diarrhea Unassociated With Ileal Resection
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
Read the 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 diarrhea. The objective is to assess the effects of this probiotic on fecal blood low acid levels in patients with bile acid diarrhea. Secondary objectives are to evaluate changes in% primary fecal bile acids in a single stool sample, serum 7 alpha C4, intestinal permeability, stool consistency and frequency, fecal short chain fatty acids, and fecal micro biome composition and diversity
- Conditions
- Bile Acid Malabsorption, Bile Acid Diarrhea
- Being tested
- De Simone formulation probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De Simone formulation probioticDietary supplement
Subjects will be given De Simone formulation probiotic 900 billion CFU, 3 times per day for 21-24 days
PlaceboDietary supplement
Subjects will be given a placebo for 21-24 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Experimental | Not described Receives: Dietary Supplement: De Simone formulation probiotic |
| Control Group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal bile acid concentration
Reported as micromoles per g stool and % primary bile acids
Measured: Baseline, 24 days
Secondary outcomes (1)
Change in intestinal permeability
Intestinal permeability will be measured using the standardized, validated 13C-mannitol and lactulose urine excretion test and reported as a ratio of the percentage excretion of lactulose and mannitol in urine
Measured: Baseline, 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start2 Jan 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Acid MalabsorptionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study of probiotic combination versus placebo in patients with bile acid diarrhea
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, MD, DSc, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609148
- Sponsor's protocol ID
- 24-003006
- Status last verified
- Jul 2026
- First submitted
- 20 Sep 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption/Diarrhea Unassociated With Ileal Resection
- ClinicalTrials.gov ID
- NCT06609148
- Acronym / sponsor ID
- 24-003006
- Conditions
- Bile Acid Malabsorption, Bile Acid Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 diarrhea. The objective is to assess the effects of this probiotic on fecal blood low acid levels in patients with bile acid diarrhea. Secondary objectives are to evaluate changes in% primary fecal bile acids in a single stool sample, serum 7 alpha C4, intestinal permeability, stool consistency and frequency, fecal short chain fatty acids, and fecal micro biome composition and diversity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled study of probiotic combination versus placebo in patients with bile acid diarrhea
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: De Simone formulation probiotic |
| Control Group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Prior diagnosis of bile acid malabsorption documented in the medical history based on
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De Simone formulation probioticSubjects will be given De Simone formulation probiotic 900 billion CFU, 3 times per day for 21-24 days | Dietary supplement | Probiotic Group |
| PlaceboSubjects will be given a placebo for 21-24 days | Dietary supplement | Control Group |
Primary outcome
Change in fecal bile acid concentration
Time frame: Baseline, 24 days
Reported as micromoles per g stool and % primary bile acids
1 secondary outcome
Change in intestinal permeability
Time frame: Baseline, 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, MD, DSc principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De Simone formulation probiotic in people with Bile Acid Malabsorption and Bile Acid Diarrhea, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fecal bile acid concentration (time frame: Baseline, 24 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.