Lactobacillus Reuteri for Treatment of Uncomplicated UTI in Pregnant Women
Condition: Urinary Tract Infection in Pregnancy
MeSH terms: Urinary Tract Infections
Study type: Interventional

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.
    

Intervention name(s): Probiotics; Antibiotics
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 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; 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
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial, double blind allocation concealment, parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment