Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental | L. gasseri oral capsule |
|
| Experimental 2 | Experimental | L. gasseri + L. crispatus oral capsule |
|
| Placebo | Placebo Comparator | Maltodextrin (E1400, qs) oral capsule once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal colonization of L. gasseri strain | Change in the vaginal concentration of L. gasseri strain measured by qPCR versus baseline | Day 0, 3, 6, 9, 12, 15 |
| Vaginal colonization of L. crispatus strain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana Maria Aldea Perona, PhD | Instituto Hospital del Mar de Investigaciones Médicas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Hospital del Mar de Investigaciones Médicas | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40772934 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
|
| Placebo | Dietary Supplement | One maltodextrin-containing capsule a day for 18 days starting the next day after menstruation is over |
|
Change in the vaginal concentration of L. crispatus strain measured by qPCR versus baseline
| Day 0, 3, 6, 9, 12, 15 |
| Vaginal microbiota composition | Change in vaginal microbiota composition measured by 16S rRNA sequencing analysis in samples obtained from vaginal swabs | Day 0, 6, 12 and 15 or 18 |
| Perianal concentration of L. crispatus strain | Change in the perianal concentration of L. crispatus strain measured by qPCR | Day 0, 9 and 15 or 18 |
| Perianal concentration of L. gasseri strain | Change in the perianal concentration of L. gasseri strain measured by qPCR | Day 0, 9 and 15 or 18 |
| Vaginal pH | Change in vaginal pH throughout study period measured by pH test strip | Day 0, 3, 6, 9, 12, 15, 18 |
| Gastrointestinal symptoms | Gastrointestinal manifestations measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe. | day 0, day 18 |
| Adverse events | Frequency of adverse events throughout study period | 18 days |
| Satisfaction with the product | Evaluation of the satisfaction with the product through the Treatment Satisfaction Questionnaire for Medication (TSQM) | Day 18 |
| D019602 |
| Food and Beverages |