Health TrialsbyHealthPanel

The Effect of ASTARTE™ on Recurrent Urinary Tract Infection

ConditionRecurrent Urinary Tract Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorHvidovre University Hospital

About this trial

Investigate the effect of dietary supplements/probiotic ASTARTE™ ( L. crispatus, L. rhamnosus, L. jensenii, L. gasseri) on the microbiome composition in the intestine and vagina and thereby a reduction of risk factors for the development of rUTI during 6 months of intervention in women aged 18-40 years. This is measured by the incidence of symptomatic UTI.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women 18-40 years of age

Recurrent UTI (2 times UTI within 6 months or > 3 times UTI infection within one year).

The subjects should be informed about the trial protocol.

The subject must be able to follow the protocol, have provided voluntary consent and have signed the declaration of consent.

Disqualifiers

Pregnancy or planning pregnancy

Breastfeeding

Participation in another trial with probiotic the last 30 days.

Hypersensitivity to any ingredient in the study product

Trial design

Design model

Parallel

Treatments tested in this trial

  • ASTARTE™ oral capsules

    Dietary supplement

    1 Capsule daily for 6 months

  • Placebo oral capsules

    Dietary supplement

    1 Capsule daily for 6 months

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: ASTARTE™ oral capsuleActive comparator 2 interventions
Group B: Placebo oral capsulePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Reduction of UTI cases

Number of symptomatic urinary tract infection cases during the intervention compared to the number of UTI cases before the intervention (\> 2 UTIs per year). Measured from a urine sample.

Time frame
6 months

Secondary outcomes

1

Number of UTI after intervention

Number of symptomatic urinary tract infection cases during the intervention compared to the number of UTI cases after the intervention. Measured from a urine sample.

Time frame
12 months
2

UTI symptoms

Change in UTI symptoms from the baseline measure by the ICIQ-FLUTS questionnaire every 2d months. We measure score values: 0-16 filling symptoms subscale, 0-12 voiding symptoms subscale, 0-20 incontinence symptoms subscale

Time frame
12 months
3

Change of vaginal microbiome

Change in vaginal microbiome from the baseline measure by Microbiome genetic test. Measure from a feacal sample every 2d month in the intervention period.

Time frame
6 months
4

Change of gut microbiome

Change in gut microbiome from the baseline measure by Microbiome genetic test. Measure from a fecal sample every 2d month in the intervention period.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hvidovre University Hospital

Lead sponsor

Source ClinicalTrials.gov
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