Cranberry for the Prevention of Urinary Tract Infections

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Urinary Infection

Intervention / Treatment
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* Dietary Supplement: ANTHOCRAN FITOSOMA
* Dietary Supplement: PLACEBO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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<br>|
| Placebo Comparator: Placebo group<br>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<br>* Placebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months<br>|

What is the study measuring?
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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 |