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Cranberry for the Prevention of Urinary Tract Infections

Primary Purpose

Diabetes, Urinary Infection

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ANTHOCRAN FITOSOMA
PLACEBO
Sponsored by
Azienda di Servizi alla Persona di Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2023
Last Updated
February 15, 2023
Sponsor
Azienda di Servizi alla Persona di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT05730998
Brief Title
Cranberry for the Prevention of Urinary Tract Infections
Official Title
The Beneficial Effects of a Cranberry-based Oral Nutritional Supplement on the Prevention of Urinary Tract Infections in Diabetic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Urinary Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
ANTHOCRAN FITOSOMA
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO
Intervention Description
Placebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months
Primary Outcome Measure Information:
Title
urinalysis
Description
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).
Time Frame
At baseline
Title
urinalysis
Description
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).
Time Frame
After two months of treatment
Title
urinalysis
Description
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).
Time Frame
After four months of treatment
Secondary Outcome Measure Information:
Title
urine culture
Description
A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.
Time Frame
At baseline
Title
urine culture
Description
A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.
Time Frame
After two months of treatment
Title
urine culture
Description
A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.
Time Frame
After four months of treatment
Title
urine culture
Description
A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.
Time Frame
After six months of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Cranberry for the Prevention of Urinary Tract Infections

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