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The Effect of ASTARTE™ on Recurrent Urinary Tract Infection (rUTI)

Primary Purpose

Recurrent Urinary Tract Infection

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ASTARTE™ oral capsules
Placebo oral capsules
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Recurrent Urinary Tract Infection focused on measuring rUTI, Probiotic

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Gastrounit, Copenhagen University Hospital HvidovreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ASTARTE™ oral capsule

Placebo oral capsule

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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.

Full Information

First Posted
September 16, 2022
Last Updated
September 21, 2022
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05553652
Brief Title
The Effect of ASTARTE™ on Recurrent Urinary Tract Infection
Acronym
rUTI
Official Title
The Effect of ASTARTE™; Lactobacillus Crispatus, Lactobacillus Rhamnosus, Lactobacillus Jenesii and Lactobacillus Gasseri on the Reduction of Risk Factors for Recurrent Urinary Tract Infection in Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Urinary tract infection (UTI) is one of the most common infections, contributing to increased antibiotic consumption and high costs. Women are often developing UTI due to the anatomically short distance from the rectum opening to the urethra. There is a risk of serious complications associated with pregnancy, where there is an increased risk of developing pelvic inflammatory disease and premature birth. This will in some cases lead to increased risk of maternal and neonatal morbidity and mortality; especially in infection with Streptococcus agalactiae. Recurrent UTI (rUTI) with urease producing microorganisms such as Proteus and Klebsiella will cause an increased risk of developing stones in the urinary tract. Scientific studies suggest that probiotics can be effective dietary supplements reducing the risk factors for the development of infections in the intestine and vagina. Probiotics are non-pathogenic microorganisms capable of affecting gastrointestinal microbiota with a change in microbiota composition, thus increasing the production of beneficial substances when ingested in appropriate quantities. The consumption of probiotics is not considered to be associated with adverse reactions to humans because they are usually found naturally in e.g. gastrointestinal and vaginal microbiota. A prospective study over 2-years which is conducted as a randomized placebo-controlled double-blind study. In this study the investigators will investigate the effect of probiotics ASTARTE™ ( Lactobacillus crispatus, Lactobacillus rhamnosus, Lactobacillus jensenii, Lactobacillus gasseri) on the composition of bacteria in urine, faces and vagina, and a possible reduction of risk factors for development of rUTI in women (18 to 40 years). The investigators will map the microbiota in the faeces and vagina and examine if there are a relationship between colonization of the urinary tract with pathogens and the composition of the intestinal and vaginal microbiota.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
rUTI, Probiotic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASTARTE™ oral capsule
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
ASTARTE™ oral capsules
Intervention Description
1 Capsule daily for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo oral capsules
Intervention Description
1 Capsule daily for 6 months
Primary Outcome Measure Information:
Title
Reduction of UTI cases
Description
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 Outcome Measure Information:
Title
Number of UTI after intervention
Description
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
Title
UTI symptoms
Description
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
Title
Change of vaginal microbiome
Description
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
Title
Change of gut microbiome
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women 18-40 years of age, Recurrent UTI (2 times UTI within 6 months or > 3 times UTI infection within one year).
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Petersen, DM. PhD
Phone
+4538626199
Email
andreas.munk.petersen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled Ghathian, phd.stud.
Phone
+38623205
Email
khaled.saoud.ali.ghathian@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Petersen, DM. PhD
Organizational Affiliation
Hvidovre Hospital, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrounit, Copenhagen University Hospital Hvidovre
City
Hvidovre
State/Province
Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas M Petersen, MD, ph.d
Phone
004538625960
Email
andreas.munk.petersen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Khaled Ghathian, ph.d. stud.
Phone
+4538623205
Email
kgha0001@regionh.dk
First Name & Middle Initial & Last Name & Degree
Andreas M Petersen, MD, ph.d.

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of ASTARTE™ on Recurrent Urinary Tract Infection

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