Status:
COMPLETED
Interventional Study to Evaluate the Effect of the Oral Administration of L.Plantarum on Vaginal Microbiota
Lead Sponsor:
AB Biotics, SA
Conditions:
Vaginal Infection
Eligibility:
FEMALE
18-55 years
Phase:
NA
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 dysbio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04461782
Start Date
April 15 2019
End Date
February 15 2020
Last Update
July 8 2020
Active Locations (1)
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1
Sta María del Rosell university hospital
Cartagena, Spain, 30203