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Completed

NCT Number: NCT03923985

Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora

Clinical trial to evaluate the effect of a probiotic containing Lactobacillus Crispatus on the vaginal flora

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Key information

Conditions

Vaginal Flora

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Palacios

Madrid, 28009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women between 18 and 45 years old
  • Women without current symptoms of vaginal infection
  • Negative bacteriological and clinical examination

Exclusion criteria

  • Women with vaginal infection
  • Women with undiagnosed vaginal bleeding
  • Patients with endometrial hyperplasia
  • Suspicion of neoplasia or active neoplasia
  • Women with intolerance, allergy or hypersensitivity to the components of the probiotic
  • Women with immunosuppressive disorders or with HIV
  • Women who are currently using probiotics by any route of administration
  • Women who are using some treatment for vaginal sepsis
  • Chronic decompensated noncommunicable diseases (diabetes mellitus, heart disease ...)
  • Pregnant women or those with precocious menopause

Treatment and study plan

Probiotic containing Lactobacillus Crispatus

Dietary Supplement

1 tablet / day of probiotic (275 mg of live probiotic lactic ferments: 10 Mld L. fermentum (SGL 10), 10 Mld L. gasseri, 10 Mld L. casei, 10 Mld L. acidophilus, 10 Mld L. crispatus) during 2 months.

Primary outcomes

  1. Changes in the number of Lactobacillus Crispatus on the vaginal flora

    Time frame: Screening, month 2

    Analysis of vaginal lactobacilli.

Secondary outcomes

  1. Changes in vaginal PH

    Time frame: Screening, month 2

    PH measurement

Sponsors and collaborators

Lead sponsor

Instituto Palacios

Other

Registry information

Official study title

Clinical Trial to Evaluate the Effect of an Oral Probiotic (Food Supplement) Containing Lactobacillus Crispatus on the Vaginal Flora

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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