Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

NCT ID: NCT06290518

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-01-29

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.

Conditions

Infertility Unexplained

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Probiotic group

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.

Group Type: EXPERIMENTAL

Ligilactobacillus salivarius CECT5713

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of a capsule containing 9.5 log10 cfu of the strain.

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of a capsule containing maltodextrin.

Interventions

Ligilactobacillus salivarius CECT5713

Oral administration of a capsule containing 9.5 log10 cfu of the strain.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oral administration of a capsule containing maltodextrin.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role: collaborator

Biosearch S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan M. Rodríguez, PhD

Role: PRINCIPAL_INVESTIGATOR

Complutense University Madrid

Locations

Biosearch S.A.U.

Granada, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Universidad Complutense de Madrid

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 33419054 (View on PubMed)

Other Identifiers

PROBIFERT P051

Identifier Type: -

Identifier Source: org_study_id

NCT05896657

Identifier Type: -

Identifier Source: nct_alias