Welcome
Support Centre
01 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Non-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections
ISRCTN ISRCTN50717094
DOI 10.1186/ISRCTN50717094
ClinicalTrials.gov identifier
EudraCT number
Public title Non-antibiotic versus Antibiotic Prophylaxis for Recurrent Urinary Tract Infections
Scientific title
Acronym The NAPRUTI-study.
Serial number at source Project 6200.0017 (ZonMw); NTR79
Study hypothesis Not provided at time of registration
Lay summary Background and study aims
Urinary tract infections (UTIs) are very common infections in women. For women with UTIs which happen more than twice a year, low dose antibiotic prophylaxis (preventative treatment) for several months can be recommended. However, this can lead to resistance of not only the bacteria responsible for the UTI but also of all the natural bacterial found on/in a healthy person.
Previous studies have demonstrated that prophylaxis with non-antibiotic compounds (lactobacilli oral therapy) compared with a dummy treatment may lead to a lower number of new UTI episodes. Cranberry juice, compared with a dummy treatment, has also resulted in fewer UTIs in women. This study aims to compare these forms of non-antibiotic prophylaxis to antibiotic prophylaxis.

Who can participate?
Women who have an indication for prophylaxis of recurrent UTIs.

What does the study involve?
Participants will be randomly allocated to one of four treatments. In study A, 280 pre-menopausal women will receive either cranberry capsules or standardized antibiotic treatment. In study B, 280 postmenopausal women will receive either lactobacilli oral therapy or standardized antibiotic treatment.
Each month, during 15 months, all patients have to fill in a short questionnaire and to collect urine, faeces and a vaginal swab. At the beginning of the study and after 6,12 and 15 months they will have to fill in a longer questionnaire about quality of life.

What are the possible benefits and risks of participating?
Not provided.

Where is the study run from?
Academic Medical Center, Amsterdam, the Netherlands.

When is the study starting and how long is it expected to run for?
September 2005 to September 2009

Who is funding the study?
The work was supported by the Netherlands Organization for Health Research and Development

Who is the main contact?
NAPRUTI@amc.uva.nl
Ethics approval Ethics approval received from the local medical ethics committee
Study design Multicentre, randomised, double blinded, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Urinary tract infections
Participants - inclusion criteria 1. Women aged 18 years or older
2. At least three symptomatic urinary tract infections (UTIs), uncomplicated or complicated, in the year preceding study inclusion OR already using any form of prophylaxis to prevent recurrences of urinary tract infections and at least three symptomatic urinary tract infections in the year befort the start of the prophylaxis
Participants - exclusion criteria 1. Life expectancy less than or equal to one year
2. Legally incapable
3. A renal transplant in the medical history
4. Contraindications for or relevant interactions with trimethoprim-sulfamethoxazole (TMP/SMX)
5. Additional exclusion criteria for trial A (pre-menopausal women randomised to either cranberry capsules or TMP/SMX):
5.1. Breastfeeding, pregnancy, or pregnancy wish for the next year
5.2. Contraindications for or relevant interactions with cranberries
Anticipated start date 01/09/2005
Anticipated end date 01/09/2009
Status of trial Completed
Patient information material
Target number of participants 560
Interventions In trial A, 280 pre-menopausal women will receive either cranberry capsules (twice daily 500 mg) or standardised antibiotic treatment (once daily 480 mg trimethoprim-sulfamethoxazole [TMP/SMX]).

In trial B, 280 postmenopausal women will receive either lactobacilli oral therapy (twice daily a capsule with greater than 10^9 Lactobacillus rhamnosus GR-1 and L. reuteri RC-14) or standardised antibiotic treatment (480 mg TMP/SMX).

The double-dummy method is used for blinding. Each patient receives one tablet and two capsules daily, but only one of them (the tablet or the capsules) contains the active substance. All study medication must be taken for the duration of 12 months. During the treatment period and the three months after stopping the treatment (wash-out period), each month patients have to fill in a short questionnaire and collect urine, faeces and a vaginal swab for culturing.
Primary outcome measure(s) 1. The numbers of recurrences of symptomatic UTI
2. Time to first occurrence of antibiotic resistance in urine or faeces
Secondary outcome measure(s) 1. Incidence of other infections
2. Incidence of asymptomatic bacteriuria events
3. Quality of life
4. Costs per prevented UTI
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications 2011 results of cranberries vs antibiotics in http://www.ncbi.nlm.nih.gov/pubmed/21788542
2012 results of lactobacilli vs antibiotics in http://www.ncbi.nlm.nih.gov/pubmed/22782199
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23406642 (article in Dutch)
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24705418
Contact name Dr  Mariëlle  Beerepoot
  Address Academic Medical Centre
Dep Infectieziekten, tropische geneeskunde en AIDS
P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Tel +31 (0)20 5667921
  Fax +31 (0)20 6972286
  Email M.A.Beerepoot@amc.uva.nl
Sponsor Academic Medical Centre (AMC) (The Netherlands)
  Address P.O. Box 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Sponsor website: http://www.amc.nl/
Date applied 12/09/2005
Last edited 10/04/2014
Date ISRCTN assigned 12/09/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.