Cranberry for the Prevention of Urinary Tract Infections

Not Applicable

Completed

• Conditions: Diabetes; Urinary Infection
• Interventions: Dietary Supplement: PLACEBO; Dietary Supplement: ANTHOCRAN FITOSOMA

• Registration Number: NCT05730998
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

Brief Summary

This research aims to evaluate the potential benefit of an oral nutritional supplement based on Anthocran phytosome compared to placebo on the prevention of urinary infections, including microbiota analyzes, in postmenopausal women (\> 70 years) with diabetes.

For each subject enrolled, all parameters relating to urinary infections will be assessed at the beginning (baseline), every 2 months from the start of treatment and at the end of treatment (6 months), with urine analysis and quality of life questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• postmenopausal women (> 70 years) with diabetes.
• treatment with SGLT-2 inhibitors
• disease duration for at least 10 years, with at least 1 episode of infection the previous year and Charlson's co-morbidity index> 6.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	PLACEBO	1 capsule of placebo will be taken 1 times a day, for 6 months, with control every 2 months and phone call every month of treatment.
Intervention group	ANTHOCRAN FITOSOMA	1 capsule (120 mg) of Anthocran phytosome will be taken 1 times a day, for 6 months, with control every 2 months and phone call every month of treatment.

Primary Outcome Measures

Name	Time	Method
urinalysis	After four months of treatment	Urinalysis included color, specific gravity, pH, glucose, protein, red blood cell, white blood cell. Microscopic examinations were performed under a clinical light microscope (Olympus Opto Systems India Pvt. Ltd. New Delhi, India).

Secondary Outcome Measures

Name	Time	Method
urine culture	After six months of treatment	A positive urinary culture was defined as growth of a single urine pathogen of \>104 cfu/mL urine specimen.

Trial Locations

Locations (1)

l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).; 🇮🇹 Pavia, Italy