Probiotic study probes gut leakiness in healthy volunteers

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: * 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.