Cranberry for the Prevention of Urinary Tract Infections

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Urinary Infection; Diabetes

Treatments: Dietary Supplement: PLACEBO; Dietary Supplement: ANTHOCRAN FITOSOMA

Study type: Interventional

Funder types: Other

Identifiers

NCT05730998

2207/01072022

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: ANTHOCRAN FITOSOMA

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: PLACEBO