Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- University of Salerno
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improvement after treatment
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Detailed Description
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).
Investigators
PAOLA IOVINO
Associate Professor
University of Salerno
Eligibility Criteria
Inclusion Criteria
- •A positive diagnosis of functional constipation or Irritable Bowel Syndrome -subtype constipation according to Rome IV criteria.
- •Negative for colon cancer screening
- •Negative relevant additional screening or consultation whenever appropriate.
- •Ability of conforming to the study protocol.
- •Stable treatment for Parkinson's disease
Exclusion Criteria
- •Presence of any other relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values a part from Parkinson's disease
- •Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
- •Previous major abdominal surgeries.
- •Inability to conform with protocol.
- •Recent history or suspicion of alcohol abuse or drug addiction.
- •Previous participation in this study.
Outcomes
Primary Outcomes
Improvement after treatment
Time Frame: 12 WEEKS
"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.
neuropsychological function
Time Frame: 12 weeks
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.
satisfaction with therapy
Time Frame: 12 weeks
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)
Secondary Outcomes
- the Unified Parkinson Disease Rating Scale (UPDRS, italian version)(12 WEEKS)
- M-PAC SYM(12 WEEKS)