Status:
COMPLETED
Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women
Lead Sponsor:
Innovacion y Desarrollo de Estrategias en Salud
Collaborating Sponsors:
BioGaia AB
Conditions:
Urinary Tract Infection in Pregnancy
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief 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 ...
Detailed Description
Randomized controlled trial, aimed to evaluate the efficacy of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938 for the treatment of pregnant women with asymptomatic bacte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2019
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03362697
Start Date
December 15 2017
End Date
June 18 2019
Last Update
June 20 2019
Active Locations (1)
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1
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, Mexico, 14080