NCT05553652

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2022Dec 2027

First Submitted

Initial submission to the registry

September 16, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

September 16, 2022

Last Update Submit

September 21, 2022

Conditions

Recurrent Urinary Tract Infection

Keywords

rUTIProbiotic

Outcome Measures

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.

    6 months

Secondary Outcomes (4)

  • Number of UTI after intervention

    12 months

  • UTI symptoms

    12 months

  • Change of vaginal microbiome

    6 months

  • Change of gut microbiome

    6 months

Study Arms (2)

ASTARTE™ oral capsule

ACTIVE COMPARATOR

The capsule will contain a mixture of four probiotic strains with a combined potency of 5 x10\^9 (CFU)/capsule: Lactobacillus crispatus LBV88, 2 x10\^9 CFU/g Lactobacillus rhamnosus LBV96, 2 x10\^9 CFU/g Lactobacillus gasseri LBV150N , 0.6 x10\^9 CFU/g Lactobacillus jensenii LBV116, 0.4 x10\^9 CFU/g Corn starch 79 mg, Magnesium salts of fatty acid 3 mg, Silicon dioxide 3 mg, Vegetal capsule size 1 DR white 75 mg, Fructooligosaccharides 30mg

Dietary Supplement: ASTARTE™ oral capsulesDietary Supplement: Placebo oral capsules

Placebo oral capsule

PLACEBO COMPARATOR

The placebo oral capsules is identical to the ASTARTE™ capsules and contains Corn starch 79 mg, Magnesium salts of fatty acid 3 mg, Silicon dioxide 3 mg, Vegetal capsule size 1 DR white 75 mg, Fructooligosaccharides 30mg

Dietary Supplement: ASTARTE™ oral capsulesDietary Supplement: Placebo oral capsules

Interventions

ASTARTE™ oral capsulesDIETARY_SUPPLEMENT

1 Capsule daily for 6 months

ASTARTE™ oral capsulePlacebo oral capsule
Placebo oral capsulesDIETARY_SUPPLEMENT

1 Capsule daily for 6 months

ASTARTE™ oral capsulePlacebo oral capsule

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen 18-40 years of age, Recurrent UTI (2 times UTI within 6 months or \> 3 times UTI infection within one year).
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy or planning pregnancy
  • Breastfeeding
  • Participation in another trial with probiotic the last 30 days.
  • Hypersensitivity to any ingredient in the study product
  • Patients primarily admitted for a disorder other than UTI
  • Antibiotic treatment for any other condition than UTI at time of recruitment the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Copenhagen, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Andreas Petersen, DM. PhD

    Hvidovre Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Petersen, DM. PhD

CONTACT

+4538626199andreas.munk.petersen@regionh.dk

Khaled Ghathian, phd.stud.

CONTACT

+38623205khaled.saoud.ali.ghathian@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor, PhD

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 23, 2022

Study Start

September 19, 2022

Primary Completion

August 1, 2024

Study Completion (Estimated)

December 1, 2027

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)