Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women

Not Applicable

Completed

• Conditions: Urinary Tract Infection in Pregnancy
• Interventions: Dietary Supplement: Probiotics; Drug: Antibiotics

• Registration Number: NCT03362697
• Lead Sponsor: Innovacion y Desarrollo de Estrategias en Salud

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 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

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 bacteriuria or uncomplicated acute cystitis. As primary outcome we will evaluate the number of cases with clinical (symptoms severity) or bacteriological cure in pregnant women with uncomplicated cystitis or asymptomatic bacteriuria after 7 days treatment with probiotics vs. placebo. As secondary outcome we will evaluate a) rate of recurrence cases in each group; b) time to relapse; c) frequency of pyelonephritis; d) birth weight and head circumference; d) number of cases of preterm babies (less than 36 weeks of gestation); e) frequency of antibiotic as rescue treatment; f) frequency of adverse related events in each arm and g) frequency of preeclampsia. Women on active group will receive a combination of at least 5\*10\^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, PAC-A and Zinc. Women in control group will receive o Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) ror patients with positive dipstick.

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-05
• Study Start: 2017-12-15
• Primary Completion: 2018-12-30
• Status Verified: 2019-06
• Study Completion: 2019-06-18
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotics	5\*10\^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, PAC-A and Zinc
Antibiotic	Antibiotics	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

Primary Outcome Measures

Name	Time	Method
Clinical and/or Bacteriological cure	14 days	Number of cases with improvement of symptoms severity and/or urinary culture during the first seven days of treatment

Secondary Outcome Measures

Name	Time	Method
Frequency of preterm babies	6 months	Number of children at delivery with \<36wekks of gestation
Recurrence rate	6 months	Rate of recurrence cases during the rest of pregnancy
Antibiotic rescue	6 months	Use of antibiotics for the treatment of pyelonephritis
Time to relapse	6 months	Time occurred since the finish of treatment until new UTI occurred
Frequency of pyelonephritis	6 months	Number of cases of pyelonephritis in each branch
Adverse events	14 days	Frequency of adverse events in each branch

Trial Locations

Locations (1)

Hospital General Dr. Manuel Gea Gonzalez; 🇲🇽 Mexico city, Tlalpan, Mexico