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Trial record 31 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

A Double-blinded, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection (UTI) in Adult Women Recently Treated for UTI.

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ClinicalTrials.gov Identifier: NCT03366077
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
BioGaia AB

Brief Summary:

Urinary tract infections (UTIs) are the most common bacterial infections in women, with about 50% of women experiencing at least one UTI in their lifetime.

The main pharmacological treatments of cystitis usually involve the use of antibiotics, in particular quinolones (such as ciprofloxacin and levofloxacin), fosfomycin, second-generation and third-generation cephalosporins, and b-lactam antibiotics associated with b-lactamase inhibitors.


Condition or disease Intervention/treatment Phase
Recurrent Urinary Tract Infection (UTI) in Adult Women Recently Treated for UTI Dietary Supplement: Probiotic Not Applicable

Detailed Description:

This is a double-blinded, randomized, placebo-controlled, parallel-group study evaluating the effect of the probiotic on recurrent urinary tract infection (UTI) in adult women recently treated for UTI.

Primary objective The primary objective is to evaluate the effect of oral supplementation with probiotic on the frequency of UTI during six months from start of intervention in adult women with recurrent UTI.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blinded, randomized, placebo-controlled, parallel-group
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Double-blinded, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Effect of the Probiotic on Recurrent Urinary Tract Infection (UTI) in Adult Women Recently Treated for UTI.
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Dietary Supplement: Probiotic
Probiotic

Placebo Comparator: Placebo Dietary Supplement: Probiotic
Probiotic




Primary Outcome Measures :
  1. Mean number of confirmed UTIs during six months from start of intervention, as compared to placebo [ Time Frame: 6 M ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healty women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Willing and able to give informed consent for participation in the study.
  2. Woman aged 18-50 years old at screening.
  3. BMI ≥18 at screening.
  4. Currently on antibiotic treatment for UTI, at the time of screening. Antibiotic treatment must stop within three days prior to first IP dose.
  5. Recurrent UTI defined as at least two UTIs during the last six months or at least three UTIs during the last 12 months, according to information given by the subject.
  6. Able and willing to comply with the restrictions defined for the the study period (see Section 10.6).
  7. Access to Bank ID and ability to use the e-health platform (i.e. Internet access).
  8. Ability to understand and comply with the requirements of the study, as judged by the Investigator.

Exclusion Criteria:

  1. Postmenopausal (defined as 12 months of amenorrhoea).
  2. Pregnant or breastfeeding.
  3. Planning to become pregnant during the study.
  4. Irregular menstruations combined with perimenopausal symptoms.
  5. Known hypersensitivity or allergy to any of the components of the test product, or to the comparator (placebo).
  6. Use of spermicide contraceptives including spermicidal condom within three days prior to first IP dose.
  7. History of complicated cystitis, urgency incontinence, recent pyelonephritis, urological and/or gynaecologist abnormalities, immunocompromised, as judged by the Investigator.
  8. Unstable bowel disorder such as diarrhoea, Crohn's disease, ulcerative colitis.


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): NCT03366077


Locations
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Sweden
Clinical Trial Consultants AB Recruiting
Uppsala, Sweden, 752 37
Contact: erik Rein-Hedin, MD    +46 768 339 888    erik.hedin@ctc-ab.se   
Contact: Anna Stendahl, PhD    +46 768 339 888    anna.stendahl@ctc-ab.se   
Sponsors and Collaborators
BioGaia AB

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Responsible Party: BioGaia AB
ClinicalTrials.gov Identifier: NCT03366077     History of Changes
Other Study ID Numbers: CSUB0144
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases