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
Abstract
Urinary tract infection (UTI) is one of the most common bacterial infections, contributing to increased antibiotic consumption and high healthcare costs. Clinical studies suggest that probiotics can be effective dietary supplements reducing the risk factors for the development of infections in the intestine and vagina. In this study, we investigate the effect of the orally ingested probiotic combination ASTARTE™ on the composition of bacteria in vaginal and fecal samples, as well as on the occurrence of bacteriologically confirmed UTIs in women of reproductive age. A randomized, placebo-controlled, double-blind study evaluating the effect of the probiotic combination ASTARTE™ (Chr. Hansen A/S, Part of Novonesis Group, Denmark) on reducing the number of recurrent urinary tract infections (rUTIs) in women aged 18–40 years. Participants are randomized (1:1) to receive one daily probiotic capsule (5 × 109 CFU) containing Lactobacillus crispatus LBV 88™ (DSM22566), Lacticaseibacillus rhamnosus LBV 96™ (DSM22560), Lactobacillus jensenii LBV 116™ (DSM22567), and Lactobacillus gasseri LBV 150N™ (DSM22583), or placebo, for 6 months. Assessments, including symptom questionnaires, urine culturing and microbiome analysis of vaginal and rectal samples by shotgun sequencing, are conducted at baseline, 2, 4, and 6 months. Compliance is tracked by unused capsule counts. Follow-up visits occur at 8, 10, and 12 months. The primary outcome is the incidence of symptomatic bacteriologically…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Association of lower urinary tract symptoms and OAB severity with quality of life and mental health in China, Taiwan and South Korea: results from a cross-sectional, population-based study
- Ten-Day Quadruple Therapy Comprising Low-Dose Rabeprazole, Bismuth, Amoxicillin, and Tetracycline Is an Effective and Safe First-Line Treatment for Helicobacter pylori Infection in a Population with High Antibiotic Resistance: a Prospective, Multicenter, Randomized, Parallel-Controlled Clinical Trial in China
- The Role of the NLR and PLR in Urinary Tract Infection
- Threat of Antimicrobial Resistance among Pilgrims with Infectious Diseases during Hajj: Lessons Learnt from COVID-19 Pandemic
- Leclercia adecarboxylata urinary tract infection in a patient with bladder cancer and recurrent hematuria
- A Case Series of Staphylococcus lugdunensis Infection in Cancer Patients at an Academic Cancer Institute in the United States
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.