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

NCT05688397 | Completed

• 1 other identifier: OLIVIA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

probiotics

Outcome Measures

Primary Outcomes (2)

• Colonization of L. crispatus strain in the vagina

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

  0,15 or 18 days

• Colonization of L. gasseri strain in the vagina

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

  0,15 or 18 days

Secondary Outcomes (9)

• Vaginal colonization of L. gasseri strain

  Day 0, 3, 6, 9, 12, 15

• Vaginal colonization of L. crispatus strain

  Day 0, 3, 6, 9, 12, 15

• Vaginal microbiota composition

  Day 0, 6, 12 and 15 or 18

• Perianal concentration of L. crispatus strain

  Day 0, 9 and 15 or 18

• Perianal concentration of L. gasseri strain

  Day 0, 9 and 15 or 18

Study Arms (3)

Experimental 1

EXPERIMENTAL

L. gasseri oral capsule

Dietary Supplement: Experimental 1

Experimental 2

EXPERIMENTAL

L. gasseri + L. crispatus oral capsule

Dietary Supplement: Experimental 2

Placebo

PLACEBO COMPARATOR

Maltodextrin (E1400, qs) oral capsule once a day

Dietary Supplement: Placebo

Interventions

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

Also known as: Probiotic

Experimental 1

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

Also known as: Probiotic mixture

Experimental 2

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women
• Reproductive age 18-45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (1)

Instituto Hospital del Mar de Investigaciones Médicas

Barcelona, Spain

Location

Related Publications (1)

• Perez M, Armengol E, Del Casale A, Campedelli I, Aldea-Perona A, Perez Otero M, Rodriguez-Palmero M, Espadaler-Mazo J, Huedo P. Lactobacillus gasseri CECT 30648 shows probiotic characteristics and colonizes the vagina of healthy women after oral administration. Microbiol Spectr. 2025 Sep 2;13(9):e0021125. doi: 10.1128/spectrum.00211-25. Epub 2025 Aug 7.

  PMID: 40772934 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ana Maria Aldea Perona, PhD

  Instituto Hospital del Mar de Investigaciones Médicas

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: February 15, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)