Clinical trial NCT04461782: Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota
Official title: Interventional Study to Evaluate the Effect of a Food Supplement Comprising L. Plantarum After Oral Intake in Vaginal Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Infection
Keywords: vaginal probiotic
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Colonization
timeFrame: change day 14-23 from baseline
measure: Colonization
timeFrame: change day 42 from baseline
Secondary outcomes:
measure: Lactobacillary grade (LBG) score
timeFrame: change day 42 from baseline
measure: Other bacteria in vagina
timeFrame: change day 14-23 from baseline
measure: Other bacteria in vagina
timeFrame: change day 42 from baseline
measure: Vaginal pH
timeFrame: Change day 14-23 from baseline
measure: Vaginal pH
timeFrame: Change day 42 from baseline
measure: Product satisfaction
timeFrame: day 14-23
measure: Safety and tolerability
timeFrame: through study completion, an average of 42 days
measure: Gastrointestinal symptoms
timeFrame: Change day 14-23 from baseline
Other outcomes:
Locations:
city: Cartagena
country: Spain
facility: Sta María del Rosell university hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.