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Completed

NCT Number: NCT05730998

Cranberry for the Prevention of Urinary Tract Infections

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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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Infections Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urinary Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. urinalysis

    Time frame: 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).

  2. urinalysis

    Time frame: After two months of treatment

    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).

  3. urinalysis

    Time frame: After four months of treatment

    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 outcomes

  1. urine culture

    Time frame: At baseline

    A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.

  2. urine culture

    Time frame: After two months of treatment

    A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.

  3. urine culture

    Time frame: After four months of treatment

    A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.

  4. urine culture

    Time frame: After six months of treatment

    A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 16, 2023
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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