Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

Study Overview
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Brief Summary
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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.

Official Title
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Modulation of the Reproductive Microbiota as a Strategy to Increase Rates of Reproductive Success in Couples With Infertility of Unknown Origin

Conditions
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Abortion, Spontaneous, Abortion in First Trimester, Infertility Unexplained

Intervention / Treatment
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* Dietary Supplement: Ligilactobacillus salivarius CECT5713
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Volunteers are classified into 2 groups. All women in the probiotic group consume (oral route) a daily capsule with  50 mg of freeze-dried probiotic ( 9 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin). All women in the placebo group consume (oral route) a daily capsule with  50 mg of maltodextrin.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic group<br>All women in the probiotic group consume (oral route) a daily capsule with  50 mg of freeze-dried probiotic ( 9 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. | Dietary Supplement: Ligilactobacillus salivarius CECT5713<br>* Oral administration of a capsule containing 9 log10 cfu of the strain.<br>|
| Placebo Comparator: Placebo group<br>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. | Dietary Supplement: Placebo<br>* Oral administration of a capsule containing maltodextrin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful pregnancies | Total number of pregnancies with delivery of a healthy baby | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of the vaginal microbiota | Variation in the concentration of lactobacilli and other microbes in vaginal samples | 9 months | 
| Vaginal immunomodulation | Variation in the concentration of immune factors in vaginal samples | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abortion, Infertility