Vaginal Infection
Conditions
Keywords
vaginal probiotic
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus plantarum
Oral food supplement
Sponsors
AB Biotics, SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Asymptomatic subjects with vaginal microbiota classified as LBG (Lactobacillary grade) I, IIa or IIb. * Using the same contraceptive within 4 weeks prior to study start.
Exclusion criteria
* Current vaginal infection. * Vaginal infection 1 month prior to study start. * Cervico-vaginal pathology. * Papilloma human virus. * Pregnant or breastfeeding mothers. * Using IUD. * Immunomodulators or systemic corticoids intake. * Vaginal or systemic antibiotics intake 1 month prior to study start. * Vaginal probiotic intake 1 month prior to study start. * Less than three months after giving birth or abortion. * Undergone vaginal or intestinal surgery three months prior to study start. * Severe stress or depression. * Systemic acute or severe disease. * History of alcohol or drug abuse. * Chronic intestinal pathology. * Not understanding protocol procedures. * Use of lubricant 24 hours or spermicide 7 days prior to study start. * Swallowing difficulties. * Impossibility to understand study procedures. * Enrolled in another clinical study. * Atrophic vaginitis not under treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colonization | change day 14-23 from baseline | Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other bacteria in vagina | change day 14-23 from baseline | Detection of other bacteria by metagenomic analysis |
| Vaginal pH | Change day 14-23 from baseline | Measured through urine test strip |
| Lactobacillary grade (LBG) score | change day 42 from baseline | 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. |
| Safety and tolerability | through study completion, an average of 42 days | Analyzed by the number of adverse events registered during the study |
| Gastrointestinal symptoms | Change day 14-23 from baseline | 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) |
| Product satisfaction | day 14-23 | Measured with a categorical scale (Likert type) going from 0 to 5 . Where 0 is very insatisfied and 5 is very satisfied |
Countries
Spain
Outcome results
None listed