Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

NCT06609148 | Recruiting

• 1 other identifier: 24-003006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.

Conditions

Bile Acid Malabsorption; Bile Acid Diarrhea

Outcome Measures

Primary Outcomes (1)

• Change in fecal bile acid concentration

  Reported as micromoles per g stool and % primary bile acids

  Baseline, 24 days

Secondary Outcomes (1)

• Change in intestinal permeability

  Baseline, 24 days

Other Outcomes (1)

• Changes in symptoms based on daily stool diary acquired for 7 days' baseline and the 21 days of intervention

  Baseline, 24 days

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Dietary Supplement: De Simone formulation probiotic

Control Group

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

De Simone formulation probiotic DIETARY_SUPPLEMENT

Subjects will be given De Simone formulation probiotic 900 billion CFU, 3 times per day for 21-24 days

Probiotic Group

Placebo DIETARY_SUPPLEMENT

Subjects will be given a placebo for 21-24 days

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Study Officials

• Michael Camilleri, MD, DSc

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Damianos, MD

CONTACT

5072842511; damianos.john@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled study of probiotic combination versus placebo in patients with bile acid diarrhea

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: January 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)