Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
- Conditions
- Infertility Unexplained
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Ligilactobacillus salivarius CECT5713
- Registration Number
- NCT06290518
- Lead Sponsor
- Biosearch S.A.
- Brief Summary
The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
- legal age
- Intention to achieve a pregnancy, but without achieving it;
- Be willing to undergo in vitro fertilization treatment;
- Be on the waiting list for the IVF cycle with an expected waiting time > 5 months.
- Sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...).
- Genitourinary malformations;
- Concurrence of other severe diseases (e.g.: cancer, AIDS, ALS, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...).
- Treatment/intervention other than the planned IVF after the start date of the intervention.
- Antibiotic treatment at the start date of the intervention.
- Intention to consume another probiotic supplement in the following 3 months.
- Participation in another clinical trial.
- Allergic/intolerant to the excipient.
- Inability to understand the informed consent form and/or to follow the basic instructions of the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo All women in the placebo group consume (oral route) a daily capsule with \~50 mg of maltodextrin during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation. Probiotic group Ligilactobacillus salivarius CECT5713 All women in the probiotic group consume (oral route) a daily capsule with \~50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin) during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation.
- Primary Outcome Measures
Name Time Method Successful pregnancies 9 months Total number of pregnancies with delivery of a healthy baby
- Secondary Outcome Measures
Name Time Method Vaginal immunomodulation 9 months Variation in the concentration of immune factors in vaginal samples. The presence and concentration of a wide spectrum of cytokines, chemokines and growth factors (IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, RANTES, TGF-β1, 2 and 3, VEGF, GRO-alpha and TNF-alpha)
Modification of the vaginal microbiota 9 months Variation in the concentration of lactobacilli and other microbes in vaginal samples (Staph ylococcus, Streptococcus, Enterococcus, Corynebacterium, Rothia, Arthrobacter, Acinetobacter, Actinomyces)
Trial Locations
- Locations (3)
Biosearch S.A.U.
🇪🇸Granada, Spain
Universidad Complutense de Madrid
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain