The effectiveness of a probiotic food supplement to restore the vaginal microbiota in postmenopausal women
| ISRCTN | ISRCTN15737648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15737648 |
- Submission date
- 03/10/2022
- Registration date
- 06/10/2022
- Last edited
- 26/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
The existence of communication between the vagina and the gut has long been recognized. It is therefore important to maintain a healthy microbiota community (microorganisms including bacteria that live in the digestive tract) for the regulation of infection in the urogenital tract. Probiotic supplementation has been suggested to maintain, through the gut microbiota, the physiological vagina microbiota with a reduction of pathogen (harmful bacteria) colonization. In this context, the use of probiotics could support women during the postmenopausal period when they are more susceptible to infections. The main aim of this study is to evaluate the effectiveness of a food supplement based on the SynBalance® Femme probiotic formulation at improving the vaginal microbiota and reducing inflammation due to vaginal infections.
Who can participate?
Healthy postmenopausal women, aged 45-65 years
What does the study involve?
The study involves taking food supplements for 28 days. The probiotic product should be taken for 4 consecutive weeks, one capsule per day. Assessments will be carried out at the time of recruitment and the start of the study and at the end of treatment with the food supplement, after 4 weeks. A telephone assessment will be performed after a 4-week follow-up period.
What are the possible benefits and risks of participating?
Risks associated with the intake of the product are considered from low to very low. The benefits associated with product use are improvement of symptoms of postmenopausal and vaginal infections.
Where is the study run from?
Colledoro Medical Centre - Siena (Italy)
When is the study starting and how long is it expected to run for?
April 2022 to March 2023
Who is funding the study?
SynBalance srl (Italy)
Who is the main contact?
Dr Franco Vicariotto, ginecologia@vicariotto.com
Contact information
Scientific
Via Milani 24
Origgio
21040
Italy
| Phone | +39 (0)2 9679 9831 |
|---|---|
| p.malfa@synbalance.care |
Principal Investigator
Via Moscova, 40
Milano
20121
Italy
| Phone | +39 (0)3356698020 |
|---|---|
| ginecologia@vicariotto.com |
Study information
| Study design | Prospective single-center interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Observational prospective study on the efficacy of a food supplement containing a probiotic blend to restore the physiological vaginal microbiota in postmenopausal women |
| Study acronym | Menopause 2022 |
| Study objectives | The main objective of this prospective, observational study is to evaluate the potential effectiveness of a food supplement based on the SynBalance® Femme probiotic formulation in improving vaginal dysbiosis, typical of menopause, and in reducing inflammation due to vaginal infections, mainly caused by aerobic microorganisms. |
| Ethics approval(s) | Approved 03/06/2022, Derming Ethics Committee (Via Valassina 29, 20159 Milano, Italy; +39 (0)3420399117; adele.sparavigna@derming.com), ref: not applicable |
| Health condition(s) or problem(s) studied | Vaginal dysbiosis and vaginal infections |
| Intervention | 50 postmenopausal women, aged between 45 and 65 years will be subjected to oral administration of a food supplement containing the SynBalance® Femme blend, consisting of Lactiplantibacillus plantarum PBS067, Bifidobacterium animalis subsp. lactis BL050 and Lacticaseibacillus rhamnosus LRH020. The probiotic product should be taken for 4 consecutive weeks, one capsule per day. The assessments relating to the state of health and effectiveness of the treatment will be carried out at the time of recruitment and the start of the study (T0) and at the end of treatment with the food supplement, after 4 weeks (T1). A telephone assessment will be performed after a 4-week follow-up period (T2). |
| Intervention type | Supplement |
| Primary outcome measure | Composition of the vaginal microbiota. The effect of the probiotic treatment on the initial menopausal vaginal dysbiosis will be evaluated as an increase in lactobacillary presence and an improvement of healthy microbiota. Measured at baseline and 4 weeks. |
| Secondary outcome measures | 1. Vaginal pH measured using litmus paper at baseline and 4 weeks 2. Dosage of pro-inflammatory cytokines (IL-6, IL-1β, TNF-α and IL-8) measured using human cytokine ELISA kits at baseline and 4 weeks 3. Vaginal well-being measured using the vaginal health index (VHI) at baseline, 4 and 8 weeks |
| Overall study start date | 22/04/2022 |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Postmenopausal women, aged 45-65 years, with last menstrual cycle more than 18 months ago 2. Women with body mass index (BMI) ≤27 kg/m² 3. Women with vaginal pH ≥5 4. Postmenopausal women with typical menopausal disorders 5. Women who intend to use the probiotic product and undergo checkups |
| Key exclusion criteria | 1. Women under hormone therapy (HT) 2. Women with BMI >27 kg/m² 3. Women who intend to use probiotic products or that used them in the last 2 weeks 4. Women with a proven allergy to the product 5. Women who have undergone antimicrobial treatment in the last 4 weeks |
| Date of first enrolment | 19/09/2022 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Siena
53100
Italy
Sponsor information
Industry
Via Milani, 24
Origgio (VA)
28100
Italy
| Phone | +39 (0)296799831 |
|---|---|
| info@synbalance.care | |
| Website | https://synbalance-probiotics.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/01/2024 | 26/02/2024 | Yes | No |
Editorial Notes
26/02/2024: Publication reference and total final enrolment added.
05/10/2022: Trial's existence confirmed by the Derming Ethics Committee.
