Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

Infertility Unexplained Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06290518
• Other study ID #: PROBIFERT P051
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Infertility
• Infertility Unexplained

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