Cranberry for the Prevention of Urinary Tract Infections

NCT ID: NCT05730998

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-01-31

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.

Detailed Description

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Conditions

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Diabetes Urinary Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

ANTHOCRAN FITOSOMA

Intervention Type 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 group

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.

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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ANTHOCRAN 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

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

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

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Pavia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2207/01072022

Identifier Type: -

Identifier Source: org_study_id

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