Effect of Probiotic on Constipation in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's Disease

Conditions
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Parkinson Disease, Constipation

Intervention / Treatment
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* Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus casei DG (Enterolactis duo®)<br>Lactobacillus casei DG (Enterolactis duo®) | Dietary Supplement: Lactobacillus casei DG (Enterolactis duo®)<br>* Lactobacillus casei DG (Enterolactis duo®)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfaction 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) | 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. | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 WEEKS | 
| M-PAC SYM | M-PAC-SYM)5 The Patient Assessment of Constipation Symptoms (scoring from 0 = absent to 4 = very strong) | 12 WEEKS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, Parkinson's disease