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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06290518
Other study ID # PROBIFERT P051
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date January 29, 2024

Study information

Verified date February 2024
Source Biosearch S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date January 29, 2024
Est. primary completion date May 3, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ligilactobacillus salivarius CECT5713
Oral administration of a capsule containing 9.5 log10 cfu of the strain.
Placebo
Oral administration of a capsule containing maltodextrin.

Locations

Country Name City State
Spain Biosearch S.A.U. Granada
Spain Hospital Clínico San Carlos Madrid
Spain Universidad Complutense de Madrid Madrid

Sponsors (3)

Lead Sponsor Collaborator
Biosearch S.A. Hospital San Carlos, Madrid, Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Successful pregnancies Total number of pregnancies with delivery of a healthy baby 9 months
Secondary Modification of the vaginal microbiota Variation in the concentration of lactobacilli and other microbes in vaginal samples (Staph ylococcus, Streptococcus, Enterococcus, Corynebacterium, Rothia, Arthrobacter, Acinetobacter, Actinomyces) 9 months
Secondary Vaginal immunomodulation Variation in the concentration of immune factors in vaginal samples. The presence and concentration of a wide spectrum of cytokines, chemokines and growth factors (IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, IFN-?, MCP-1, MIP-1ß, RANTES, TGF-ß1, 2 and 3, VEGF, GRO-alpha and TNF-alpha) 9 months
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