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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Placebo group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANTHOCRAN FITOSOMA | Dietary Supplement | 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 |
|
| 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 |
| 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. |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP). | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| PLACEBO | Dietary Supplement | Placebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months |
|
| 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 |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |