Clinical trial NCT06290518: Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
Official title: Modulation of the Reproductive Microbiota as a Strategy to Increase Rates of Reproductive Success in Couples With Infertility of Unknown Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Unexplained
Keywords: Infertility
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
Collaborators: name: Hospital San Carlos, Madrid
name: Universidad Complutense de Madrid
First posted: 2024-03-04
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment 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 (9.5 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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Successful pregnancies
timeFrame: 9 months
Secondary outcomes:
measure: Modification of the vaginal microbiota
timeFrame: 9 months
measure: Vaginal immunomodulation
timeFrame: 9 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Biosearch S.A.U.
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
affiliation: Complutense University Madrid
name: Juan M. Rodríguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez L, Castro I, Arroyo R, Alba C, Beltran D, Rodriguez JM. Application of Ligilactobacillus salivarius CECT5713 to Achieve Term Pregnancies in Women with Repetitive Abortion or Infertility of Unknown Origin by Microbiological and Immunological Modulation of the Vaginal Ecosystem. Nutrients. 2021 Jan 6;13(1):162. doi: 10.3390/nu13010162.