Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota
- Conditions
- Vaginal Infection
- Interventions
- Dietary Supplement: Lactobacillus plantarum
- Registration Number
- NCT04461782
- Lead Sponsor
- AB Biotics, SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lactobacillus plantarum Lactobacillus plantarum Oral intake 1 cap daily 1E+09 cfu/cap of Lactobacillus plantarum
- Primary Outcome Measures
Name Time Method Colonization change day 42 from baseline Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
- Secondary Outcome Measures
Name Time Method Vaginal pH Change day 42 from baseline Measured through urine test strip
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
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.
Other bacteria in vagina change day 42 from baseline Detection of other bacteria by metagenomic analysis
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)
Safety and tolerability through study completion, an average of 42 days Analyzed by the number of adverse events registered during the study
Trial Locations
- Locations (1)
Sta María del Rosell university hospital
🇪🇸Cartagena, Spain