Palliative Care Centre "Panagia Glykofilousa"
Thessaloniki, Central Macedonia, Greece
NCT Number: NCT07432763
The goal of this clinical study is to learn if Pomegranate Seed Oil supplementation works to combat urinary tract infections, recurrenturinary tract infections, or pneumonia and contributes to the tapering or discontinuation of antipsychotics in palliative care patients withadvanced dementia.
The main questions it aims to answer are:
* Does Pomegranate Seed Oil supplementation reduce the likelihood of developing a urinary tract infection? * Does Pomegranate Seed Oil supplementation prevent UTI reinfection? * Does Pomegranate Seed Oil supplementation reduce the likelihood of pneumonia? * Does Pomegranate Seed Oil supplementation contribute to the tapering or discontinuation of antipsychotics?
Researchers will compare Pomegranate Seed Oil to care-as-usual to see if Pomegranate Seed Oil supplementation can increase quality of care in palliative care patients with advanced dementia.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Thessaloniki, Central Macedonia, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Besides Pomegranate Seed Oil Supplementation, all participants will continue to receive all ongoing care and treatments, including following the Mediterranean diet, monthly neuropsychological and behavioural assessments, physiotherapy, cognitive stimulation, occupational therapy and music therapy, without any modification
All participants will continue to receive all ongoing care and treatments, including a Mediterranean diet,monthly neuropsychological and behavioural assessments, physiotherapy, cognitive stimulation,occupational therapy and music therapy, without any modification
Time frame: From enrollment to the end of treatment at 24 weeks
Urinary Tract Infections were diagnosed using the revised McGeer criteria for the diagnosis of UTIs in Stone et al. (2012):
Criteria from both 1 and 2
Acute dysuria or acute pain, swelling, or tenderness of the testes, epididymis, or prostate OR
Fever or leukocytosis and at least 1 of the following localizing urinary tract sub-criteria:
Acute costovertebral angle pain or tenderness Suprapubic pain Gross hematuria New or marked increase in incontinence New or marked increase in urgency New or marked increase in frequency
In the absence of fever or leukocytosis, then 2 or more of the following:
Suprapubic pain Gross hematuria New or marked increase in incontinence New or marked increase in urgency New or marked increase in frequency
At least 10^5 cfu/mL of no more than 2 species of microorganisms in a voided urine sample At least 10^2 of any number of organisms in a specimen collected by in-and-out catheter
Time frame: From enrollment to the end of treatment at 24 weeks
Recurrent UTIs were classified as more than one UTI diagnosed in a single patient based on the criteria proposed in Stone et al. (2012) as described previously.
Time frame: From enrollment to the end of treatment at 24 weeks
Time frame: From enrollment to the end of treatment at 24 weeks
As in Stone et al. (2012):
All 3 criteria must be present:
Panhellenic Federation of Alzheimer's Disease and Related Disorders
Other
Effects of a Twenty-Four-Week Pomegranate Seed Oil Supplementation in Palliative Care Patients With Advanced Dementia: A Double Blind, Randomized Controlled Clinical Study
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