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Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.

NCT03701893 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-22

No results posted yet for this study

Summary

Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus PS11610

7 months and a half intervention study. A 6 months intervention period preceded by a period of sampling and analysis of vaginal, seminal and gland swabs of 6 weeks. During the 6 months of intervention the men participants will intake one capsule that contains 1\*10E9 colony forming unit (CFU) of Lactobacillus PS11610 and the women participating will intake two capsules of the same product (each 12 hours). If the couple stay pregnant during the intervention the man will end the product intake and the woman will reduce the dose to one capsule with 1\*10E9 CFU of Lactobacillus PS11610 per day during 12 additional weeks.

Sponsors & Collaborators

  • ProbiSearch SL

    lead INDUSTRY

Principal Investigators

  • Susana Manzano, PhD · ProbiSearch SL

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT03701893 on ClinicalTrials.gov