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Completed

NCT Number: NCT05688397

Evaluation of the Vaginal Colonization of Two New Lactobacillus Strains After Oral Administration in Healthy Volunteers

Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days. Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota and vaginal pH

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Hospital del Mar de Investigaciones Médicas

Barcelona, Spain

About this study

Double blind, randomized, placebo-controlled biomedical research study to determine whether supplementation with the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina. Healthy women who meet inclusion and exclusion criteria will be randomized 1.5:1.5:1 to one of the following study groups: group one will receive L.gasseri for 18 days (1 capsule/day), group two will recieve the combination of L.gasseri and L.Crispatus for 18 days (1 capsule/day) and the other will receive placebo, starting the day after menstruation is over. Main study outcome will be colonization throughout the study, which will be determined by analysis of specific strains by qPCR. Secondary outcomes comprise comprise evaluation of tolerability, impact on vaginal microbiota, vaginal pH and adverse events.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy women
  • Reproductive age 18-45 years

Exclusion criteria

  • Vaginal infection or symptoms (AMSEL criteria).
  • Relevant disease (immunodeficiency, cervicovaginal pathology, diabetes, estrogen-dependent tumors, inflammatory bowel disease, atrophic vaginitis, pancreatitis)
  • Suffer from chronic diarrhea or constipation or short bowel syndrome,
  • Having taken systemic or vaginal antibiotics or antifungals during the month prior to study entry.
  • Pregnant women or willing to be during the study, lactating women.
  • Having taken another probiotic during the month prior to study entry orally or vaginally. This includes food supplements or foods supplemented with probiotics such as Actimel, Activia or similar.
  • Intake of immunomodulators or systemic corticosteroids.
  • History of alcohol or drug abuse.
  • Menopausal women.
  • Use of the IUD.
  • Use of spermicides or vaginal lubricants during the month prior to study entry.
  • Very irregular periods or low probability of going at least 18 days without menstruation (short cycles).
  • Have participated in a clinical trial during the month prior to entering the study.
  • Not being able to follow or understand study procedures. This includes not being willing to maintain sexual abstinence during the 24 hours prior to each vaginal sample collection.
  • Any other condition not compatible with the study according to the investigators

Treatment and study plan

Experimental 1

Dietary Supplement

L. gasseri oral capsule once a day (1 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over

Other names: Probiotic

Experimental 2

Dietary Supplement

L. gasseri and L. crispatus oral capsule once a day (1.5 x 10^9 CFU/day) for 18 days starting the next day after menstruation is over

Other names: Probiotic mixture

Placebo

Dietary Supplement

One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over

Primary outcomes

  1. Colonization of L. crispatus strain in the vagina

    Time frame: 0,15 or 18 days

    Change in the concentration of L. crispatus strain throughout study period measured by qPCR in samples obtained with vaginal swab

  2. Colonization of L. gasseri strain in the vagina

    Time frame: 0,15 or 18 days

    Change in the concentration of L. gasseri strain throughout study period measured by qPCR in samples obtained with vaginal swab

Secondary outcomes

  1. Vaginal colonization of L. gasseri strain

    Time frame: Day 0, 3, 6, 9, 12, 15

    Change in the vaginal concentration of L. gasseri strain measured by qPCR versus baseline

  2. Vaginal colonization of L. crispatus strain

    Time frame: Day 0, 3, 6, 9, 12, 15

    Change in the vaginal concentration of L. crispatus strain measured by qPCR versus baseline

  3. Vaginal microbiota composition

    Time frame: Day 0, 6, 12 and 15 or 18

    Change in vaginal microbiota composition measured by 16S rRNA sequencing analysis in samples obtained from vaginal swabs

  4. Perianal concentration of L. crispatus strain

    Time frame: Day 0, 9 and 15 or 18

    Change in the perianal concentration of L. crispatus strain measured by qPCR

  5. Perianal concentration of L. gasseri strain

    Time frame: Day 0, 9 and 15 or 18

    Change in the perianal concentration of L. gasseri strain measured by qPCR

  6. Vaginal pH

    Time frame: Day 0, 3, 6, 9, 12, 15, 18

    Change in vaginal pH throughout study period measured by pH test strip

  7. Gastrointestinal symptoms

    Time frame: day 0, day 18

    Gastrointestinal manifestations measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe.

  8. Adverse events

    Time frame: 18 days

    Frequency of adverse events throughout study period

  9. Satisfaction with the product

    Time frame: Day 18

    Evaluation of the satisfaction with the product through the Treatment Satisfaction Questionnaire for Medication (TSQM)

Sponsors and collaborators

Lead sponsor

AB Biotics, SA

Industry

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Vaginal Colonization Capacity, Safety, and Tolerability of Two New Strains of L. Gasseri and L. Crispatus When Administered Orally in Healthy Female Volunteers

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Jul 20, 2023

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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