RECRUITING

Probiotic in Patients With Bile Acid Malabsorption/Diarrhea

Conditions

Bile Acid Malabsorption Bile Acid Diarrhea

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption/Diarrhea Unassociated With Ileal Resection

Quick Facts

Study Start:2024-12-20

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06609148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

John Damianos, MD

CONTACT

5072842511

damianos.john@mayo.edu

Principal Investigator

Michael Camilleri, MD, DSc

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Michael Camilleri, MD, DSc, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-20

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-12-20

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Bile Acid Malabsorption
Bile Acid Diarrhea