Diabetes, Urinary Infection
Conditions
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.
Interventions
DIETARY_SUPPLEMENTANTHOCRAN 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
DIETARY_SUPPLEMENTPLACEBO
Placebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinalysis | At baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| urine culture | At baseline | A positive urinary culture was defined as growth of a single urine pathogen of \>104 cfu/mL urine specimen. |
Countries
Italy
Outcome results
None listed