Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

Biosearch Life

Status: Completed

Conditions: Infertility Unexplained

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Ligilactobacillus salivarius CECT5713

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06290518

PROBIFERT P051

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ligilactobacillus salivarius CECT5713

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo