Condition category
Urological and Genital Diseases
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
10/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mariëlle Beerepoot

ORCID ID

Contact details

Academic Medical Centre
Dep Infectieziekten
tropische geneeskunde en AIDS
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5667921
M.A.Beerepoot@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Project 6200.0017 (ZonMw); NTR79

Study information

Scientific title

Acronym

The NAPRUTI-study.

Study hypothesis

Not provided at time of registration

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, double blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Urinary tract infections

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

Cranberry capsule, trimethoprim-sulfamethoxazole, lactobacilli oral therapy

Primary outcome measures

1. The numbers of recurrences of symptomatic UTI
2. Time to first occurrence of antibiotic resistance in urine or faeces

Secondary outcome measures

1. Incidence of other infections
2. Incidence of asymptomatic bacteriuria events
3. Quality of life
4. Costs per prevented UTI

Overall trial start date

01/09/2005

Overall trial end date

01/09/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

560

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

01/09/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results of cranberries vs antibiotics

    Beerepoot MA, ter Riet G, Nys S, van der Wal WM, de Borgie CA, de Reijke TM, Prins JM, Koeijers J, Verbon A, Stobberingh E, Geerlings SE, Cranberries vs antibiotics to prevent urinary tract infections: a randomized double-blind noninferiority trial in premenopausal women., Arch. Intern. Med., 2011, 171, 14, 1270-1278, doi: 10.1001/archinternmed.2011.306.

  2. Results of lactobacilli vs antibiotics

    Beerepoot MA, ter Riet G, Nys S, van der Wal WM, de Borgie CA, de Reijke TM, Prins JM, Koeijers J, Verbon A, Stobberingh E, Geerlings SE, Lactobacilli vs antibiotics to prevent urinary tract infections: a randomized, double-blind, noninferiority trial in postmenopausal women., Arch. Intern. Med., 2012, 172, 9, 704-712, doi: 10.1001/archinternmed.2012.777.

  3. Results

    Bosmans JE, Beerepoot MA, Prins JM, ter Riet G, Geerlings SE, Cost-effectiveness of cranberries vs antibiotics to prevent urinary tract infections in premenopausal women: a randomized clinical trial., PLoS ONE, 2014, 9, 4, e91939, doi: 10.1371/journal.pone.0091939.

Additional files

Editorial Notes