Clinical trial NCT06609148: Probiotic in Patients With Bile Acid Malabsorption/Diarrhea
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption/Diarrhea Unassociated With Ileal Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bile Acid Malabsorption
Bile Acid Diarrhea
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study of probiotic combination versus placebo in patients with bile acid diarrhea
Primary purpose: TREATMENT

Brief summary: 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

Eligibility 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

Primary outcomes:
measure: Change in fecal bile acid concentration
timeFrame: Baseline, 24 days
Secondary outcomes:
measure: Change in intestinal permeability
timeFrame: Baseline, 24 days
Other outcomes:
measure: Changes in symptoms based on daily stool diary acquired for 7 days' baseline and the 21 days of intervention
timeFrame: Baseline, 24 days
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References: