Cranberry for the Prevention of Urinary Tract Infections

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05730998
• Other study ID #: 2207/01072022
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetes
• Infections
• Urinary Infection
• Urinary Tract Infections

Intervention

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
Placebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months

Locations

Country	Name	City	State
Italy	l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	urine culture	A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.	At baseline
Secondary	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
Secondary	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
Secondary	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