Vaginal HealthNCT03574844
Effect of Oral Probiotic Yeast on the Composition of the Vaginal Microbiota in Healthy Women
A study testing Saccharomyces cerevisiae, dose 500 and Saccharomyces cerevisiae, dose 1000 in people with Vaginal Health, run by Lesaffre International at 1 site in France.
Trial summary
This study is designed to evaluate the impact of oral consumption of the probiotic yeast CNCM I-3856 on healthy vaginal microbiota Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Health
- What is being tested?
- Saccharomyces cerevisiae, dose 500 and Saccharomyces cerevisiae, dose 1000
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 15 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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,
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- 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,
- Planning to travel for a long time during the study duration or not able to be contacted for emergency reason during the study available,
- Presenting a psychological or linguistic incapacity to understand and sign the informed consent,
- Participating in another clinical trial or in exclusion period from a previous clinical trial,
- Having received, during the last 12 months, countervailing indemnities for clinical trial higher or equal to 4500 Euros,
- Under legal protection (guardianship, wardship) or deprived from her rights following judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Effect of Oral Probiotic Yeast on the Composition of the Vaginal Microbiota in Healthy Women
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
- Being tested
- Saccharomyces cerevisiae, dose 500, Saccharomyces cerevisiae, dose 1000, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces cerevisiae, dose 500Dietary supplement
Experimental arm
Saccharomyces cerevisiae, dose 1000Dietary supplement
Experimental arm
PlaceboDietary supplement
Placebo comparator arm
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces cerevisiae, dose 500 | Experimental | Saccharomyces cerevisiae CNCM I-3856, 500 mg per day (2 capsules), for 4 weeks Receives: 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 Receives: Dietary Supplement: Saccharomyces cerevisiae, dose 1000 |
| Placebo | Placebo comparator | Maize starch and magnesium stearate, 1 g per day (2 capsules), for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 28
Secondary outcomes (7)
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 1, 2 or 3-week daily supplementation and after a 2-week observation period without supplementation
Measured: Day 7, Day 14, Day 21, Day 42
Quantification of S cerevisiae in the vagina
Value at Day 7, 14, 21, 28, 42 and change Day 42 - Day 28 of S cerevisiae CNCM I-3856 (CFU/ sample) in the vaginal microbiota
Measured: Day 7, Day 14, Day 21, Day 28, Day 42
Impact on 4 predominant Lactobacilli species
Changes of 4 dominant Lactobacilli species (number of copies per sample) by comparison of the 3 groups at each time change
Measured: 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
Evaluation of the presence of S cerevisiae CNCM I-3856 in the vaginal microbiota considering its presence in the intestinal microbiota in each active group.
Measured: 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
Correlation between the quantity of S cerevisiae CNCM I-3856 (CFU/sample) in the intestinal microbiota and vaginal microbiota in each active group.
Measured: Day 7, Day 14, Day 21, Day 28, Day 42
Presence of Candida albicans in the vaginal microbiota
In each group, at each time point according to Day 0 and at Day 42 according to Day 28
Measured: Day 7, Day 14, Day 21, Day 28, Day 42
Evolution of the presence of Candida albicans in the vaginal microbiota
Changes of Candida albicans (CFU/samples) in the vaginal microbiota
Measured: Day 7, Day 14, Day 21, Day 28, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Mar 2018
- Primary completion15 Jan 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, 3 parallel-arms, pilot clinical study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis, Merieux NutriSciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574844
- Sponsor's protocol ID
- 2017-A02709-44
- Status last verified
- Jun 2018
- First submitted
- 11 Jun 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Effect of Oral Probiotic Yeast on the Composition of the Vaginal Microbiota in Healthy Women
- ClinicalTrials.gov ID
- NCT03574844
- Acronym / sponsor ID
- 2017-A02709-44
- Conditions
- Vaginal Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis, Merieux NutriSciences
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the impact of oral consumption of the probiotic yeast CNCM I-3856 on healthy vaginal microbiota
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled, 3 parallel-arms, pilot clinical study
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces cerevisiae, dose 500 | Experimental | Dietary Supplement: Saccharomyces cerevisiae, dose 500Saccharomyces cerevisiae CNCM I-3856, 500 mg per day (2 capsules), for 4 weeks |
| Saccharomyces cerevisiae, dose 1000 | Experimental | Dietary Supplement: Saccharomyces cerevisiae, dose 1000Saccharomyces cerevisiae CNCM I-3856, 1 g per day (2 capsules), for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaize starch and magnesium stearate, 1 g per day (2 capsules), for 4 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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),
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saccharomyces cerevisiae, dose 500Experimental arm | Dietary supplement | Saccharomyces cerevisiae, dose 500 |
| Saccharomyces cerevisiae, dose 1000Experimental arm | Dietary supplement | Saccharomyces cerevisiae, dose 1000 |
| PlaceboPlacebo comparator arm | Dietary supplement | Placebo |
Primary outcome
S cerevisiae transfer from the gut to the vagina
Time frame: Day 28
Proportion of subjects presenting the yeast strain S cerevisiae CNCM I-3856 (presence) in their vaginal microbiota after a 4-week daily supplementation
7 secondary outcomes
S cerevisiae transfer from the gut to the vagina
Time frame: Day 7, Day 14, Day 21, Day 42
Quantification of S cerevisiae in the vagina
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Impact on 4 predominant Lactobacilli species
Time frame: 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
Time frame: 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
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Presence of Candida albicans in the vaginal microbiota
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Evolution of the presence of Candida albicans in the vaginal microbiota
Time frame: Day 7, Day 14, Day 21, Day 28, Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces cerevisiae, dose 500 and Saccharomyces cerevisiae, dose 1000 in people with Vaginal Health, run by Lesaffre International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S cerevisiae transfer from the gut to the vagina (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.