Cranberry for the Prevention of Urinary Tract Infections

The Beneficial Effects of a Cranberry-based Oral Nutritional Supplement on the Prevention of Urinary Tract Infections in Diabetic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Urinary Infection
• Intervention / Treatment: Dietary supplement: ANTHOCRAN FITOSOMA; Dietary supplement: PLACEBO

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Dietary supplement: ANTHOCRAN FITOSOMA; The product (Anthocran phytosome or placebo) will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months
Placebo Comparator: Placebo group; 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.	Dietary supplement: PLACEBO; Placebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinalysis	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).	At baseline
urinalysis	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).	After two months of treatment
urinalysis	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).	After four months of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine culture	A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.	At baseline
urine culture	A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.	After two months of treatment
urine culture	A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.	After four months of treatment
urine culture	A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.	After six months of treatment

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: 2207/01072022

Drug and device information, study documents

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