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Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women

NCT03362697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-06-20

No results posted yet for this study

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

Conditions

  • Urinary Tract Infection in Pregnancy

Interventions

DIETARY_SUPPLEMENT

Probiotics

The Probiotic group will receive Sachet 1 - contains an instant cranberry drink, consisting of xylitol, monosodium citrate, cranberry aroma, cranberry extract, grape-skin extract, xanthan gum, acesulfame potassium and zinc gluconate and Sachet 2 - contains a total of 5\*10\^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, mixed with maltodextrin. Both Sachets should be administered Day 1-14, twice per day This group will also receive for Placebo for Antibiotic treatment day 1-7, twice per day

DRUG

Antibiotics

Patient in this group will receive for 7 days Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) for patients with positive nitrates in dipstick. This group will also receive for placebo for probiotics 2 sachets for 14 days

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Innovacion y Desarrollo de Estrategias en Salud

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2018-12-30
Completion
2019-06-18

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03362697 on ClinicalTrials.gov