Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin

NCT04446572 | Completed Phase 2 DMC

• 1 other identifier: PREPROBIFERT01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we aimed to assess the cervicovaginal environment (pH, Nugent score, soluble immune factors and bacterial profile) in women with reproductive failure because of either repetitive abortion or infertility of unknown origin and compare it to that of healthy fertile women. The second objective was to evaluate the ability of Lactobacillus salivarius CECT5713 to modulate such parameters and to increase pregnancy rates in women with reproductive failure. The administration of L. salivarius CECT5713 (\~9 log10 colony-forming units (CFU)/day) for 6 months or until a diagnosis of pregnancy to women with reproductive failure resulted in an overall successful (term) pregnancy rate of 56%.

Conditions

Abortion, Spontaneous; Abortion in First Trimester; Infertility Unexplained

Keywords

Infertility; Abortion

Outcome Measures

Primary Outcomes (1)

• Pregnancies and successful pregnancies

  Total number of pregnancies and number of pregnancies with delivery of a healthy baby

  6 months

Secondary Outcomes (2)

• Modification of the vaginal microbiota

  6 months

• Vaginal immunomodulation

  6 months

Study Arms (3)

Repetitive Abortion (RA) group

EXPERIMENTAL

Starting at day 0, women of the RA (n=21) group consumed (oral route) a daily sachet with \~50 mg of freeze-dried probiotic (\~9 log10 CFU of L. salivarius CECT5713) for 6 months or until a diagnosis of pregnancy (whatever happened first).

Biological: Lactobacillus salivarius CECT5713

Infertility (INF) group

EXPERIMENTAL

Starting at day 0, women of the INF group (n=23) consumed (oral route) a daily sachet with \~50 mg of freeze-dried probiotic (\~9 log10 CFU of L. salivarius CECT5713) for 6 months or until a diagnosis of pregnancy (whatever happened first).

Biological: Lactobacillus salivarius CECT5713

Control group

NO INTERVENTION

The control group (n = 14) included fertile women having at least two children after uncomplicated term pregnancies.

Interventions

Lactobacillus salivarius CECT5713 BIOLOGICAL

Starting at day 0, women of the RA and INF groups consumed (oral route) a daily sachet with \~50 mg of freeze-dried probiotic (\~9 log10 CFU of L. salivarius CECT5713) for 6 months or until a diagnosis of pregnancy (whatever happened first).

Infertility (INF) group; Repetitive Abortion (RA) group

Eligibility Criteria

• Age: 33 Years - 41 Years
• Gender Eligibility Details: The targets were abortion or female infertility of unknown origin
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Recurrent miscarriage with three or more pregnancy losses during the first 12 weeks of pregnancy (RA group)
• Infertility (inability to conceive) despite being the recipients of ART for at least three times, including two cycles, at least, of in vitro fertilization (IVF) (INF group).
• Fertile women having at least two children after uncomplicated term pregnancies (Control group).

You may not qualify if:

• Antiphospholipid syndrome
• Hormonal therapy, antibiotics or probiotics in the 4 weeks previous to sampling.
• Lactose intolerance or cow's milk protein allergy (RA and INF groups)

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Bisearch Life: collaborator
• Centro de Diagnóstico Médico. Ayuntamiento de Madrid.: collaborator

Study Sites (1)

Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Abortion, Spontaneous; Infertility

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Juan M Rodríguez, PhD

  Complutense University Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Volunteers were classified into 3 groups. All women in the RA group (n = 21) had a history of recurrent miscarriage with three or more pregnancy losses during the first 12 weeks of pregnancy. All women of the INF group (n = 23) had a history of infertility (inability to conceive) despite being the recipients of assisted-reproduction techniques (ART) for at least three times, including two cycles, at least, of in vitro fertilization (IVF). Finally, the control group (n = 14) included fertile women having at least two children after uncomplicated term pregnancies. Starting at day 0, women of the RA and INF groups consumed (oral route) a daily sachet with \~50 mg of freeze-dried probiotic (\~9 log10 CFU of L. salivarius CECT5713) for 6 months or until a diagnosis of pregnancy (whatever happened first).

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: October 16, 2018
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will be available to other researchers once the study is published.
• Access Criteria: On request

Locations

ES (1)