Constipation, Parkinson Disease
Conditions
Keywords
constipation, Parkinson's disease
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).
Interventions
DIETARY_SUPPLEMENTLactobacillus casei DG (Enterolactis duo®)
Lactobacillus casei DG (Enterolactis duo®)
Sponsors
Roberto Erro
Maria Teresa Pellecchia
Antonella Santonicola
Carolina Ciacci
University of Salerno
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| satisfaction with therapy | 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) |
| Improvement after treatment | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Unified Parkinson Disease Rating Scale (UPDRS, italian version) | 12 WEEKS | 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) |
| M-PAC SYM | 12 WEEKS | M-PAC-SYM)5 The Patient Assessment of Constipation Symptoms (scoring from 0 = absent to 4 = very strong) |
Countries
Italy
Contacts
Primary ContactPAOLA IOVINO, MD
Outcome results
None listed