Overview

Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women

Status:
Completed
Trial end date:
2019-06-18
Target enrollment:
0
Participant gender:
Female
Summary
Prevalence of uro-genital infections during pregnancy move between 7% to 12% in developed countries, meanwhile in developing countries this figure moved between 14% and until 55%, such is the case of Mexico. Meanwhile use of antibiotics for 3 to 7 days had established as a standard of care, the use of non-antibiotic therapy, such as cranberry powder or probiotics for prevention/treatment of this conditions is scarce. Randomized controlled trial aimed to evaluate the safety and efficacy of probiotic vs. antibiotics to treat pregnant women with uncomplicated cystitis or asymptomatic bacteriuria
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Innovacion y Desarrollo de Estrategias en Salud
Collaborator:
BioGaia AB
Treatments:
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids
Nitrofurantoin
Criteria
Inclusion Criteria:

- Healthy women on the second or third trimester of pregnancy with positive urine
culture according to the operational definition with or without symptoms

- Age 18 to 40 years

- Verbal and Written Informed Consent for participation in the study

Exclusion Criteria:

- Pathologic pregnancy (different for UTI)

- No supplementation of probiotics 2 weeks before study start or during the study
period.

- Antibiotic therapy within last 2 weeks before randomization

- Known allergies towards the ingredients of the experimental product

- Inability to comprehend the study protocol

- Systemic diseases

- Multiple pregnancy