Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

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.

Study Overview

• Status: Recruiting
• Conditions: Bile Acid Malabsorption; Bile Acid Diarrhea
• Intervention / Treatment: Dietary supplement: De Simone formulation probiotic; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Damianos, MD; Phone Number: 5072842511; Email: damianos.john@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Michael Camilleri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Dietary supplement: Placebo; Subjects will be given a placebo for 21-24 days
Experimental: Probiotic Group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal bile acid concentration	Reported as micromoles per g stool and % primary bile acids	Baseline, 24 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 24 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in symptoms based on daily stool diary acquired for 7 days' baseline and the 21 days of intervention	The stool diary will measure stool consistency based on the Bristol Stool Form Scale (BSFS) from 1 to 7 where 7 is watery stool and 1 is hard stool and therefore a small number indicated a favorable outcome	Baseline, 24 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael Camilleri, MD, DSc, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 22, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Signs and Symptoms, Digestive; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Diarrhea; Malabsorption Syndromes
• Other Study ID Numbers: 24-003006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No