An interventional study of Probiotics and Antibiotics in Urinary Tract Infection in Pregnancy, sponsored by Innovacion y Desarrollo de Estrategias en Salud. Completed at 1 site in Mexico. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-06-20.
Sponsored by Innovacion y Desarrollo de Estrategias en Salud · Not applicable, Interventional, and Treatment
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
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.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 150 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Innovacion y Desarrollo de Estrategias en Salud is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5\*10\^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 \& Lactobacillus reuteri DSM 17938, PAC-A and Zinc
Dietary Supplement: Probiotics
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
Drug: Antibiotics
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
Clinical and/or Bacteriological cure
Number of cases with improvement of symptoms severity and/or urinary culture during the first seven days of treatment
Time frame: 14 days
Recurrence rate
Rate of recurrence cases during the rest of pregnancy
Time frame: 6 months
Time to relapse
Time occurred since the finish of treatment until new UTI occurred
Time frame: 6 months
Frequency of pyelonephritis
Number of cases of pyelonephritis in each branch
Time frame: 6 months
Frequency of preterm babies
Number of children at delivery with \<36wekks of gestation
Time frame: 6 months
Antibiotic rescue
Use of antibiotics for the treatment of pyelonephritis
Time frame: 6 months
Adverse events
Frequency of adverse events in each branch
Time frame: 14 days
Plan to share: No
Ran from Dec 2017 to primary completion in Dec 2018, 12 months.
Of 136 non-industry interventional studies with no phase under Urinary Tract Infections, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's 12 months is below that.
Counting every sponsor, half of 153 studies reached it within 22 months; a quarter within 8 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Innovacion y Desarrollo de Estrategias en Salud