The Effect of ASTARTE™ on Recurrent Urinary Tract Infection

NCT ID: NCT05553652

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2027-12-01

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.

Conditions

Recurrent Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

ASTARTE™ oral capsules

Intervention Type: DIETARY_SUPPLEMENT

1 Capsule daily for 6 months

Placebo oral capsules

Intervention Type: DIETARY_SUPPLEMENT

1 Capsule daily for 6 months

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

Group Type: PLACEBO_COMPARATOR

ASTARTE™ oral capsules

Intervention Type: DIETARY_SUPPLEMENT

1 Capsule daily for 6 months

Placebo oral capsules

Intervention Type: DIETARY_SUPPLEMENT

1 Capsule daily for 6 months

Interventions

ASTARTE™ oral capsules

1 Capsule daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo oral capsules

1 Capsule daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andreas Munk Petersen

MD, Associate Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Petersen, DM. PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre Hospital, University of Copenhagen

Locations

Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Copenhagen, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Andreas Petersen, DM. PhD

Role: CONTACT

andreas.munk.petersen@regionh.dk

+4538626199

Khaled Ghathian, phd.stud.

Role: CONTACT

khaled.saoud.ali.ghathian@regionh.dk

+38623205

Facility Contacts

Andreas M Petersen, MD, ph.d

Role: primary

andreas.munk.petersen@regionh.dk

004538625960

Khaled Ghathian, ph.d. stud.

Role: backup

kgha0001@regionh.dk

+4538623205

Other Identifiers

H-22014666

Identifier Type: -

Identifier Source: org_study_id