DiabetesNCT05730998
Cranberry for the Prevention of Urinary Tract Infections
A study testing ANTHOCRAN FITOSOMA in people with Diabetes and Urinary Infection, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Diabetes, Urinary Infection
- What is being tested?
- ANTHOCRAN FITOSOMA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
Pavia, 27100
About this study
Official title: The Beneficial Effects of a Cranberry-based Oral Nutritional Supplement on the Prevention of Urinary Tract Infections in Diabetic Subjects
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.
- Conditions
- Diabetes, Urinary Infection
- Being tested
- ANTHOCRAN FITOSOMA, PLACEBO
- Medical subject headings
- Diabetes Mellitus, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTHOCRAN FITOSOMADietary 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
PLACEBODietary supplement
Placebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: ANTHOCRAN FITOSOMA |
| 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. Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: After four months of treatment
Secondary outcomes (4)
urine culture
A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.
Measured: At baseline
urine culture
A positive urinary culture was defined as growth of a single urine pathogen of >104 cfu/mL urine specimen.
Measured: 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.
Measured: 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.
Measured: After six months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730998
- Sponsor's protocol ID
- 2207/01072022
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beneficial Effects of a Cranberry-based Oral Nutritional Supplement on the Prevention of Urinary Tract Infections in Diabetic Subjects
- ClinicalTrials.gov ID
- NCT05730998
- Acronym / sponsor ID
- 2207/01072022
- Conditions
- Diabetes, Urinary Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: ANTHOCRAN FITOSOMA1 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 | Dietary Supplement: PLACEBO1 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANTHOCRAN FITOSOMAThe product (Anthocran phytosome or placebo) will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months | Dietary supplement | Intervention group |
| PLACEBOPlacebo will be taken in the quantity of 1 capsule of 120 mg, 1 times a day, for 6 months | Dietary supplement | Placebo group |
Primary outcome
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).
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).
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).
4 secondary outcomes
urine culture
Time frame: At baseline
urine culture
Time frame: After two months of treatment
urine culture
Time frame: After four months of treatment
urine culture
Time frame: After six months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANTHOCRAN FITOSOMA in people with Diabetes and Urinary Infection, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinalysis (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.