Effects of the probiotic Saccharomyces boulardii CNCM I-745 and the antibiotic Amoxicillin on the gut microbiota of healthy volunteers An open-label, randomized, parallel groups, monocentric study

Phase 1

• Conditions: Healthy volunteers; MedDRA version: 19.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2016-003654-33-DE
• Lead Sponsor: BIOCODEX

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-27
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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
oA negative urine pregnancy test immediately prior to starting the study treatment
oAgreement 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified