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Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis.
Probiotics are living organisms that provide the host certain benefits. Despite probiotics have been historically linked to intestinal microbiota, several research groups have published positive results for some Lactobacillus strains in vaginal microbiota. The Lactobacillus strain investigated in the presented project showed the ability to prevent recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence.
Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps, however oral intake is widely preferred among consumers. Because of that, this study aims to determine whether this Lactobacillus strain is able to colonize vaginal microbiota when administered orally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus plantarum | Experimental | Oral intake 1 cap daily 1E+09 cfu/cap of Lactobacillus plantarum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum | Dietary Supplement | Oral food supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colonization | Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis | change day 14-23 from baseline |
| Colonization | Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis | change day 42 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Lactobacillary grade (LBG) score | obtained by cytology analysis by pathologists and calculated according to Donders et al., 2002. Higher scores imply more severe conditions. Scale ranges from 1 to 3. | change day 42 from baseline |
| Other bacteria in vagina |
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Inclusion Criteria:
Exclusion Criteria:
Subjects must be female in order to sample vaginal microbiota
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sta MarÃa del Rosell university hospital | Cartagena | 30203 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12954951 | Background | Reid G, Bruce AW. Urogenital infections in women: can probiotics help? Postgrad Med J. 2003 Aug;79(934):428-32. doi: 10.1136/pmj.79.934.428. | |
| 9553803 | Background | Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available. |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Detection of other bacteria by metagenomic analysis |
| change day 14-23 from baseline |
| Other bacteria in vagina | Detection of other bacteria by metagenomic analysis | change day 42 from baseline |
| Vaginal pH | Measured through urine test strip | Change day 14-23 from baseline |
| Vaginal pH | Measured through urine test strip | Change day 42 from baseline |
| Product satisfaction | Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied | day 14-23 |
| Safety and tolerability | Analyzed by the number of adverse events registered during the study | through study completion, an average of 42 days |
| Gastrointestinal symptoms | Analyzed by the validated Spanish translation of Gastrointestinal Symptom Rating Scale (GSRS) according to Kulich et al., 2005. Score ranges from 0 to 90 where 0 is no symptoms at all and 90 is the highest severity in all symptoms assessed (e.g. pain, bloating, etc) | Change day 14-23 from baseline |
| 27393491 | Background | Palacios S, Espadaler J, Fernandez-Moya JM, Prieto C, Salas N. Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504). Eur J Clin Microbiol Infect Dis. 2016 Oct;35(10):1701-8. doi: 10.1007/s10096-016-2715-8. Epub 2016 Jul 9. |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |