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Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

NCT06290518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-03-04

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Ligilactobacillus salivarius CECT5713

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

DIETARY_SUPPLEMENT

Placebo

Oral administration of a capsule containing maltodextrin.

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    collaborator OTHER

  • Universidad Complutense de Madrid

    collaborator OTHER

  • Biosearch S.A.

    lead INDUSTRY

Principal Investigators

  • Juan M. Rodríguez, PhD · Complutense University Madrid

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-05-03
Completion
2024-01-29

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06290518 on ClinicalTrials.gov