RECRUITING

Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function

Conditions

Quick Navigation

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

This study is being done to assess the effects of S. boulardii CNCM I-745 compared to placebo on impaired intestinal permeability, which is the control of material passing from inside the gastrointestinal tract through the cells lining the gut wall into the rest of the body.

Official Title

Effects of Saccharomyces Boulardii CNCM I-745 on Intestinal Barrier Function

Quick Facts

Study Start:2023-04-13

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05538247

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:25 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination). * With a body mass index (BMI) comprised between 18 and 35 kg/m\^2 and weight \> 50 kg at Screening. * Able to comply with study requirements and to provide signed informed consent. * Has signed the informed consent form before beginning any study procedure. * Regular defecation (frequency and stool consistency, with at least about three bowel movements a week). * For women of childbearing potential: * A negative urine pregnancy test immediately prior to starting the study treatment; * 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.	* History of hypersensitivity to the study treatments (active substance or excipients), brewer's or baker's yeast. * Contraindication and special warning to the study treatments according to the Summary of Product Characteristics (SmPCs). * History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average. * History of chronic or recurrent diarrhea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily. * Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago). * History of Clostridium difficile infection. * Active gastrointestinal disease. * Known chronic or recurrent systemic disorder (including diabetes and hypertension) that may interfere with the study treatment evaluation. * Associated immune deficiency. * Severe hepatic or renal impairment. * Clinically relevant abnormalities in results of laboratory tests as per Investigator's judgement. * Patients with a central venous catheter. * Oral or systemic antibacterial therapy during the 3 months prior to study enrollment. * NSAIDs and proton pump inhibitor treatment longer than 1 week, within 3 months prior to study enrollment. * Steroids within 6 weeks prior to study enrollment. * Use of medications affecting gastrointestinal transit or permeability within 7 days prior to the testing. * Use of artificial sweeteners, lactulose, mannitol within 2 days prior to the testing and during the 24 h testing period. * New prescription medications during the 2 weeks prior to study enrollment. * Use of probiotics or drugs that alters gut microbiota or function, during 4 weeks prior to study enrollment. * Intake of antifungals within 14 days prior to study enrollment. * Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, as assessed by the Investigator. * Current smoker. * History or presence of drug or alcohol abuse. * Inability to abstain from intensive muscular effort the day before the intestinal permeability test. * Breast-feeding woman. * Patients enrolled in another clinical trial within the past 30 days. * Patients not able to fill in the study questionnaires. * 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.

Inclusion Criteria

Exclusion Criteria

* Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).
* With a body mass index (BMI) comprised between 18 and 35 kg/m\^2 and weight \> 50 kg at Screening.
* Able to comply with study requirements and to provide signed informed consent.
* Has signed the informed consent form before beginning any study procedure.
* Regular defecation (frequency and stool consistency, with at least about three bowel movements a week).
* For women of childbearing potential:
* A negative urine pregnancy test immediately prior to starting the study treatment;
* 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.

* History of hypersensitivity to the study treatments (active substance or excipients), brewer's or baker's yeast.
* Contraindication and special warning to the study treatments according to the Summary of Product Characteristics (SmPCs).
* History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average.
* History of chronic or recurrent diarrhea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily.
* Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago).
* History of Clostridium difficile infection.
* Active gastrointestinal disease.
* Known chronic or recurrent systemic disorder (including diabetes and hypertension) that may interfere with the study treatment evaluation.
* Associated immune deficiency.
* Severe hepatic or renal impairment.
* Clinically relevant abnormalities in results of laboratory tests as per Investigator's judgement.
* Patients with a central venous catheter.
* Oral or systemic antibacterial therapy during the 3 months prior to study enrollment.
* NSAIDs and proton pump inhibitor treatment longer than 1 week, within 3 months prior to study enrollment.
* Steroids within 6 weeks prior to study enrollment.
* Use of medications affecting gastrointestinal transit or permeability within 7 days prior to the testing.
* Use of artificial sweeteners, lactulose, mannitol within 2 days prior to the testing and during the 24 h testing period.
* New prescription medications during the 2 weeks prior to study enrollment.
* Use of probiotics or drugs that alters gut microbiota or function, during 4 weeks prior to study enrollment.
* Intake of antifungals within 14 days prior to study enrollment.
* Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, as assessed by the Investigator.
* Current smoker.
* History or presence of drug or alcohol abuse.
* Inability to abstain from intensive muscular effort the day before the intestinal permeability test.
* Breast-feeding woman.
* Patients enrolled in another clinical trial within the past 30 days.
* Patients not able to fill in the study questionnaires.
* 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.

Contacts and Locations

Study Contact

Monique Torres

CONTACT

507-538-6599

torres.monique@mayo.edu

Principal Investigator

Michael Camilleri, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Michael Camilleri, MD, 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 Date2023-04-13

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-04-13

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Healthy