Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID05553652

The Effect of ASTARTE17; Lactobacillus Crispatus, Lactobacillus Rhamnosus, Lactobacillus Jenesii and Lactobacillus Gasseri on the Reduction of Risk Factors for Recurrent Urinary Tract Infection in Women

Led by Hvidovre University Hospital · Updated on 2022-09-23

720

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effect of a dietary supplement called ASTARTE17, which contains four probiotic strains (Lactobacillus crispatus, L. rhamnosus, L. jensenii, and L. gasseri), on the microbiome in the intestine and vagina. The study focuses on women aged 18 to 40 years who have recurrent urinary tract infections (rUTI). The goal is to see if ASTARTE17 can reduce risk factors for rUTI, measured by the number of symptomatic UTIs over six months. Participants will take one capsule daily for six months. One group will receive the ASTARTE17 probiotic capsules, while the other group will receive placebo capsules identical in appearance but without the probiotic strains. The study is randomized and double-blind, meaning neither participants nor researchers know who receives which capsules. The study will map bacterial composition in urine, feces, and vaginal samples to examine relationships between microbiota and urinary tract infections. During the study, participants will be monitored for urinary tract infection occurrences and changes in the vaginal and gut microbiome at six and twelve months. Researchers will collect samples and evaluate symptoms and the number of infections. The study also includes safety monitoring and follows participants for up to two years, with the primary outcome being the reduction of UTI cases after six months of treatment.

CONDITIONS

Brief Title

The Effect of ASTARTE™ on Recurrent Urinary Tract Infection

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women 18 to 40 years of age
  • Have recurrent urinary tract infections (at least 2 within 6 months or more than 3 within one year)
  • Have been informed about the trial protocol
  • Able to follow the study protocol, provide voluntary consent, and sign the consent form
Not Eligible

You will not qualify if you...

  • Currently pregnant or planning to become pregnant
  • Breastfeeding
  • Participated in another probiotic trial within the last 30 days
  • Allergic or hypersensitive to any ingredient in the study product
  • Mainly admitted for a condition other than urinary tract infection
  • Receiving antibiotic treatment for any condition other than urinary tract infection within the last 30 days

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants take one capsule daily of either ASTARTE™ probiotic or placebo for 6 months.

Monthly visits during treatment

Follow-up

Duration - 6 months

Participants are monitored for urinary tract infection symptoms and microbiome changes after treatment ends.

Quarterly visits during follow-up

Trial Site Locations

Total: 1 location

1

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Copenhagen, Denmark, 2650

Actively Recruiting

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Research Team

A

Andreas Petersen, DM. PhD

K

Khaled Ghathian, phd.stud.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

The effect of the probiotic supplement-ASTARTE™-on the reduction of recurrent urinary tract infection in women aged 18-40 years: protocol for a randomized, double-blind, placebo-controlled study.

Khaled Saoud Ali Ghathian, Sofie Ingdam Halkjær, Karen Angeliki Krogfelt...

https://pubmed.ncbi.nlm.nih.gov/41943076