Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis

NCT04639544 | Unknown

• 1 other identifier: P049
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.

Conditions

Recurrent Vulvovaginal Candidiasis

Keywords

Recurrent Vulvovaginal Candidiasis; Prevention; Probiotics

Outcome Measures

Primary Outcomes (2)

• Recurrence of candidiasis events

  Total candidiasis events during intervention

  6 months

• Time between episodes

  Days from baseline until candidiasis events

  6 months

Secondary Outcomes (6)

• Determination of Candida in vaginal exudate by culture analysis

  6 months

• Microbiota of vaginal exudate

  6 months

• Gynecological examination

  6 months

• pH of vaginal discharge

  6 months

• Test of related clinical symptoms

  6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

Volunteers will take 1 capsule per day with maltodextrin for 6 months

Dietary Supplement: Placebo

Probiotic group

EXPERIMENTAL

Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months

Dietary Supplement: Lactobacillus strain

Interventions

Placebo DIETARY_SUPPLEMENT

Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits

Control group

Lactobacillus strain DIETARY_SUPPLEMENT

Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits

Probiotic group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women from 18 to 49 years old.
• Having suffered at least four outbreaks of vaginal yeast infection in the last year.
• Signed Informed Consent Form.
• Agree to provide the scheduled samples.
• Agree to perform gynecological examinations
• Agree to report candidiasis events that occur during the study.
• Ability to complete surveys.

You may not qualify if:

• Being currently consuming or having consumed a probiotic in the two weeks prior to the study.
• Being under antibiotic treatment at the time of beginning the study.
• Being under pharmacological treatment for the treatment of candidiasis.
• Have an allergy to an antibiotic

Sponsors & Collaborators

• Biosearch S.A.: lead

Study Sites (1)

Hospital Universitario Infanta Elena

Valdemoro, Madrid, 28342, Spain

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Study Officials

• Jose Maldonado Lobón, PhD

  Biosearch S.A.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Maldonado Lobón, PhD

CONTACT

+34 616556789; jamaldonado@biosearchlife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: November 20, 2020
• Study Start: February 15, 2021
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)