Healthy volunteers MedDRA version: 19.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Ultra-Levure®
Product Name: Ultra-Levure®
Pharmaceutical Form: Capsule
INN or Proposed INN: Saccharomyces boulardii
Current Sponsor code: CNCM I-745
Other descriptive name: SACCHAROMYCES
Sponsors
BIOCODEX
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects enrolled in the study will have to fulfill the following criteria: 1) Healthy volunteers aging from 18 to 65 years (male or female) 2) Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests and electrocardiogram (ECG) 3) With a body mass index (BMI) comprised between 18.5 and 30.0 kg/m2 and weight >50 kg at Screening 4) Able to comply with study requirements and to provide signed informed consent 5) No clinically relevant abnormalities in results of laboratory tests as per Investigator’s judgement 6) For women of childbearing potential o A negative urine pregnancy test immediately prior to starting the study treatment o 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with one of the following criteria will not be enrolled in this study: 1) History of hypersensitivity to Saccharomyces boulardii, brewer’s or baker’s yeast, amoxicillin or any other penicillin 2) History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam) 3) Hypersensitivity to the active substance, to one of the ingredients, to any of the penicillins or to any of the excipients of the study drugs 4) Contraindication and special warning to the study drugs according to the SmPCs 5) History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average 6) History of chronic or recurrent diarrhea with spontaneous unformed bowel movements equivalent to or more often than 3 times daily 7) Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy performed at least more than one year ago) 8) History of Clostridium difficile infection 9) Known chronic or recurrent systemic disorder that may interfere with the study drug evaluation 10) Associated immune deficiency 11) Severe hepatic or renal impairment 12) Active gastrointestinal disease 13) Patients with a central venous catheter 14) Oral or systemic antibacterial therapy during the 3 months prior to study enrollment 15) New prescription medications during the 2 weeks prior to study enrollment 16) Use of any drug that alters gut microbiota or function, such as laxatives, antiemetics, cisapride, antisecretory or adsorbent treatments (racecadotril, smectite, activated charcoal), opiates such as loperamide, atropine and other cholinergic agents, during 4 weeks prior to study enrollment 17) Intake of antifungals within 14 days prior to study enrollment 18) Substantial changes in eating habits within 30 days prior to receiving the first dose of IMP product, as assessed by the Investigator 19) Patients enrolled in another clinical trial within the past 30 days 20) 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. 21) Current smoker 22) Breast-feeding woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall goals of this study are to characterize the changes in the human microbiota that result from the ingestion of the antibiotic Amoxicillin and to evaluate the ability of S. boulardii CNCM I-745 to prevent, diminish or shorten these changes. The primary objective is to assess the preventive effects of S. boulardii CNCM I-745 on the gut microbiota changes induced by Amoxicillin in the healthy volunteers. ;Secondary Objective: The secondary objective is to describe the clinical characteristics of the subjects.;Primary end point(s): The primary endpoint will be the change in the gut microbiota, using species richness, species diversity, PCA, and individual Operational Taxonomic Units (OTUs) frequencies. Thus, communities will be described using species richness, species diversity, Principal Coordinate Analysis (PCA), and individual OTU frequencies. ANOVA and discriminant analyses will differentiate the microbiota according to the presence or absence of treatments. The frequencies of OTUs in this analysis will serve to indicate the resilience of microbial communities to antibiotic treatment, and the ability of probiotics to preserve or restore OTU frequencies to approximate those of the normal gut microbiota.;Timepoint(s) of evaluation of this end point: (-21 to -7 days), Day 0, Day3, Day 7, Day 10, Day 14, Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following population characteristics: physical examination, ECG, vital signs, safety blood and urinary laboratory tests, serology, alcohol breath test, drug screen;Timepoint(s) of evaluation of this end point: The population characteristics will be described for all of the parameters collected at the screening The comparability of the treatment groups at baseline will be evaluated. | — |
Countries
Germany
Contacts
Public ContactAnke Heiermann
CTC North GmbH & Co.KG
Outcome results
None listed