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

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ClinicalTrials.gov Identifier: NCT03362697
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Pedro Gutierrez Castrellon, 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

Condition or disease Intervention/treatment Phase
Urinary Tract Infection in Pregnancy Dietary Supplement: Probiotics Drug: Antibiotics Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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)
Masking Description: Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial on the Safety and Efficacy of Lactobacillus Reuteri DSM 16666/ATCC 55845 & Lactobacillus Reuteri DSM 17938 for Treatment of Pregnant Women With Asymptomatic Bacteriuria or Uncomplicated Acute Cystitis
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Probiotic
5*10^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 & Lactobacillus reuteri DSM 17938, PAC-A and Zinc
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

Active Comparator: Antibiotic
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
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




Primary Outcome Measures :
  1. Clinical and/or Bacteriological cure [ Time Frame: 14 days ]
    Number of cases with improvement of symptoms severity and/or urinary culture during the first seven days of treatment


Secondary Outcome Measures :
  1. Recurrence rate [ Time Frame: 6 months ]
    Rate of recurrence cases during the rest of pregnancy

  2. Time to relapse [ Time Frame: 6 months ]
    Time occurred since the finish of treatment until new UTI occurred

  3. Frequency of pyelonephritis [ Time Frame: 6 months ]
    Number of cases of pyelonephritis in each branch

  4. Frequency of preterm babies [ Time Frame: 6 months ]
    Number of children at delivery with <36wekks of gestation

  5. Antibiotic rescue [ Time Frame: 6 months ]
    Use of antibiotics for the treatment of pyelonephritis

  6. Adverse events [ Time Frame: 14 days ]
    Frequency of adverse events in each branch



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362697


Locations
Mexico
Hospital General Dr. Manuel Gea Gonzalez
Mexico city, Tlalpan, Mexico, 14080
Sponsors and Collaborators
Innovacion y Desarrollo de Estrategias en Salud
BioGaia AB

Publications of Results:

Responsible Party: Pedro Gutierrez Castrellon, Head of Research, Innovacion y Desarrollo de Estrategias en Salud
ClinicalTrials.gov Identifier: NCT03362697     History of Changes
Other Study ID Numbers: CSUB 0139
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Nitrofurantoin
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors
Anti-Infective Agents, Urinary
Renal Agents