Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women (UTIPregnant)

Innovation and Development of Health Strategies

Status: Completed

Conditions: Urinary Tract Infection in Pregnancy

Treatments: Drug: Antibiotics; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03362697

CSUB 0139

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Probiotic

Experimental group

Description:

5\*10\^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, PAC-A and Zinc

Treatment:

Dietary Supplement: Probiotics

Antibiotic

Active Comparator group

Description:

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

Treatment:

Drug: Antibiotics