Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

Biosearch S.A.72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Infertility Unexplained

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (3)

Biosearch S.A.U.

Granada, Spain

Hospital Clínico San Carlos

Madrid, Spain

Universidad Complutense de Madrid

Madrid, Spain

Outcomes

Primary Outcomes

Successful pregnancies

Total number of pregnancies with delivery of a healthy baby

Time frame: 9 months

Secondary Outcomes

Modification of the vaginal microbiota

Variation in the concentration of lactobacilli and other microbes in vaginal samples (Staph ylococcus, Streptococcus, Enterococcus, Corynebacterium, Rothia, Arthrobacter, Acinetobacter, Actinomyces)

Time frame: 9 months

Vaginal immunomodulation

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)

Time frame: 9 months