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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Urinary Tract Infection
• Intervention / Treatment: Dietary supplement: ASTARTE™ oral capsules; Dietary supplement: Placebo oral capsules

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.

• Study Type: Interventional
• Enrollment (Anticipated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Petersen, DM. PhD; Phone Number: +4538626199; Email: andreas.munk.petersen@regionh.dk
• Study Contact Backup: Name: Khaled Ghathian, phd.stud.; Phone Number: +38623205; Email: khaled.saoud.ali.ghathian@regionh.dk

Study Locations

• Denmark
  • Copenhagen
    • Hvidovre, Copenhagen, Denmark, 2650
      • Recruiting
      • Gastrounit, Copenhagen University Hospital Hvidovre
      • Contact: Andreas M Petersen, MD, ph.d; Phone Number: 004538625960; Email: andreas.munk.petersen@regionh.dk
      • Principal Investigator: Andreas M Petersen, MD, ph.d.
      • Contact: Khaled Ghathian, ph.d. stud.; Phone Number: +4538623205; Email: kgha0001@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ASTARTE™ oral capsule; 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 capsules; 1 Capsule daily for 6 months; Dietary supplement: Placebo oral capsules; 1 Capsule daily for 6 months
Placebo Comparator: Placebo oral capsule; 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 capsules; 1 Capsule daily for 6 months; Dietary supplement: Placebo oral capsules; 1 Capsule daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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	12 months
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.	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Andreas Petersen, DM. PhD, Hvidovre Hospital, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Probiotic; rUTI
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Recurrence; Urinary Tract Infections
• Other Study ID Numbers: H-22014666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No