The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance
The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis® duo) effect on overall abdominal pain, bowel movements and other abdominal symptoms and on neuropsychological performance in patients with Parkinson's Disease. The investigators suppose that, due to the immunomodulatory action of probiotics, overall neuropsychological function will improve as well as due also to prebiotic abdominal symptoms will decrease following consumption of Lactobacillus casei DG (Enterolactis® duo).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Lactobacillus casei DG (Enterolactis duo®)
Aou Sangiovanni E Ruggi D'Aragona
Salerno, Italy
RECRUITINGsatisfaction with therapy
A "satisfaction with therapy" score (on a 7-point Likert scale: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = dissatisfied, 4 = partially satisfied, 5 = satisfied, 6 = very satisfied, 7 = extremely satisfied)
Time frame: 12 weeks
Improvement after treatment
"Improvement after treatment" was evaluated with a global rating-of-change scale (-7 to +7: -7 = extremely worsened, 0 = unchanged, +7 = extremely improved). "Improvement after treatment" was defined by an increase in the global rating-of-change scale of ≥2 points.
Time frame: 12 WEEKS
neuropsychological function
The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients at all stages of PD.The total NMSS score ranges from 0 to 360, the worst.
Time frame: 12 weeks
the Unified Parkinson Disease Rating Scale (UPDRS, italian version)
the Unified Parkinson Disease Rating Scale (UPDRS, italian version). The UPDRS is a rating tool used to gauge the course of Parkinson's disease in patients. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability); The Non-motor-symptoms scale (NMSS, italian version)
Time frame: 12 WEEKS
M-PAC SYM
M-PAC-SYM)5 The Patient Assessment of Constipation Symptoms (scoring from 0 = absent to 4 = very strong)
Time frame: 12 WEEKS
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