Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

NCT06290518 | Completed

• 1 other identifier: PROBIFERT P051
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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

Keywords

Infertility

Outcome Measures

Primary Outcomes (1)

• Successful pregnancies

  Total number of pregnancies with delivery of a healthy baby

  9 months

Secondary Outcomes (2)

• Modification of the vaginal microbiota

  9 months

• Vaginal immunomodulation

  9 months

Study Arms (2)

Probiotic group

EXPERIMENTAL

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.

Dietary Supplement: Ligilactobacillus salivarius CECT5713

Placebo group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Ligilactobacillus salivarius CECT5713 DIETARY_SUPPLEMENT

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

Probiotic group

Placebo DIETARY_SUPPLEMENT

Oral administration of a capsule containing maltodextrin.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The target is infertility of unknown origin. The outcome is a successful pregnancy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosearch S.A.: lead
• Hospital San Carlos, Madrid: collaborator
• Universidad Complutense de Madrid: collaborator

Study Sites (3)

Biosearch S.A.U.

Granada, 18004, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Related 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.

  PMID: 33419054 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Juan M. Rodríguez, PhD

  Complutense University Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple (Participant, Care Provider, Investigator) Only one person of the collaborator that provides the capsules (Biosearch Life) know the correspondecs between each reference (one reference per each subject) and the arm (probiotic or placebo). The codes are blinded for the participant, the care provider and the investigator.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: March 4, 2024
• Study Start: September 1, 2020
• Primary Completion: May 3, 2023
• Study Completion: January 29, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: All the raw data will be available to other researchers once the study is published.
• Access Criteria: Our intention is that all the raw data will be available as a supplementary tables in an open acess journal. They will be also provided on request.

Locations

ES (3)