Effect of Oral Probiotic Yeast on the Composition of the Vaginal Microbiota in Healthy Women

NCT03574844 | Completed

• 1 other identifier: 2017-A02709-44
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the impact of oral consumption of the probiotic yeast CNCM I-3856 on healthy vaginal microbiota

Conditions

Vaginal Health

Outcome Measures

Primary Outcomes (1)

• S cerevisiae transfer from the gut to the vagina

  Proportion of subjects presenting the yeast strain S cerevisiae CNCM I-3856 (presence) in their vaginal microbiota after a 4-week daily supplementation

  Day 28

Secondary Outcomes (7)

• S cerevisiae transfer from the gut to the vagina

  Day 7, Day 14, Day 21, Day 42

• Quantification of S cerevisiae in the vagina

  Day 7, Day 14, Day 21, Day 28, Day 42

• Impact on 4 predominant Lactobacilli species

  Day 7, Day 14, Day 21, Day 28, Day 42

• Association between intestinal and vaginal microbiota for the presence of S cerevisiae CNCM I-3856

  Day 7, Day 14, Day 21, Day 28, Day 42

• Correlation between the quantity of S cerevisiae CNCM I-3856 (CFU/sample) in the intestinal microbiota and vaginal microbiota

  Day 7, Day 14, Day 21, Day 28, Day 42

Study Arms (3)

Saccharomyces cerevisiae, dose 500

EXPERIMENTAL

Saccharomyces cerevisiae CNCM I-3856, 500 mg per day (2 capsules), for 4 weeks

Dietary Supplement: Saccharomyces cerevisiae, dose 500

Saccharomyces cerevisiae, dose 1000

EXPERIMENTAL

Saccharomyces cerevisiae CNCM I-3856, 1 g per day (2 capsules), for 4 weeks

Dietary Supplement: Saccharomyces cerevisiae, dose 1000

Placebo

PLACEBO COMPARATOR

Maize starch and magnesium stearate, 1 g per day (2 capsules), for 4 weeks

Dietary Supplement: Placebo

Interventions

Saccharomyces cerevisiae, dose 500 DIETARY_SUPPLEMENT

Experimental arm

Saccharomyces cerevisiae, dose 500

Saccharomyces cerevisiae, dose 1000 DIETARY_SUPPLEMENT

Experimental arm

Saccharomyces cerevisiae, dose 1000

Placebo DIETARY_SUPPLEMENT

Placebo comparator arm

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian or Asian women,
• With regular menstrual cycles, assessed as 28 days ± 3 days,
• With a normal vaginal flora : Nugent score ≤ 3,
• With the same efficient contraception method since at least 3 months before the start of the study, and accepting to maintain this program over the study. Authorized contraception methods: hormonal contraception (pill, patch, implant and intrauterine device), tubal ligation, ESSURE system and copper intrauterine device (without hormone),
• Agreeing to keep unchanged her intimate hygiene rules during the all duration of the study (same stable intimate hygiene habits since at least 3 months before the start of the study),
• Good general and mental health compatible with the study participation and allowing to be followed in ambulatory way according to the investigator opinion: no clinically significant and relevant abnormalities of medical history or physical examination;
• Having stable life habits since at least 3 months and accepting to maintain them stable during the study (dietary habits, tobacco and alcohol consumptions, physical activity and sexual activity),
• Tobacco consumption ≤ 10 cigarettes per day,
• Able and willing to participate to the study by complying with the protocol procedures (especially concerning study product consumption and biological samples collections), as evidenced by her dated and signed informed consent form,
• Affiliated with a social security scheme,
• Agreeing to be registered on the national file of volunteers participating in biomedical research.

You may not qualify if:

• Having hypersensitivity history to one of the ingredients of the study products,
• Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other uncontrolled metabolic disorder,
• Suffering from a severe chronic disease (e.g. cancer, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis, chronic respiratory trouble, chronic gastro-intestinal disorder, cardiac disease, immunodeficiency…) or diseases found to be inconsistent with the conduct of the study by the investigator (controlled arterial hypertension accepted),
• Suffering from Sexually Transmitted Infection (STI) or Disease (STD) such as HIV (Human Immunodeficiency Virus), B and C hepatitis, HPV (Human PapillomaVirus), Chlamydia infection, syphilis, gonorrhea, genital herpes, etc,
• Currently suffering or having suffer from bacterial, fungal, parasitic or viral infection of the uro-gynecological sphere (vaginitis, cystitis, cervix infection…), treated or not, in the 6 months previous to the study start,
• Having medical history or current pathology which could affect the study results or expose the subject to an additional risk according to the investigator,
• Currently pregnant, or lactating, intending to be pregnant within 2 months ahead or pregnancy and/or breastfeeding finished since less than 3 months,
• Ongoing symptoms of vaginal and/or urinary infection (belong to symptoms questionnaire) at the moment of the V0 and V1 visits,
• Recent history of radiotherapy (less than 6 months),
• Menopausal or pre-menopausal,
• With menstruation which usually lasts more than 7 days,
• Under chronic treatment with corticosteroids and/or immune modulator (immunostimulant, immunosuppressant…) or last intake within 3 months before the start of the study,
• Currently under medication or dietary supplement, oral or local, which could affect study parameters: antibiotic, antifungal, probiotic, prebiotic, symbiotic, phytoestrogens, etc, or stopped within a too short time window before study start (less than 4 weeks) ,
• Having a lifestyle deemed incompatible with the study according to the investigator (specific diet (vegetarian, vegan, hypocolaric…), alcohol consumption \> 2 glasses / day, physical activity \> 10 hours / week…),
• With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,

Sponsors & Collaborators

• Lesaffre International: lead
• Biofortis Mérieux Nutriscience: collaborator

Study Sites (1)

Biofortis Mérieux Nutriscience

Saint-Herblain, 44800, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, 3 parallel-arms, pilot clinical study

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 2, 2018
• Study Start: March 1, 2018
• Primary Completion: January 15, 2019
• Study Completion: February 15, 2019
• Last Updated: May 21, 2019

Record last verified: 2018-06

Locations

FR (1)