Pre-biotics and Probiotics for Constipation in Parkinson's Disease

Study Overview
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Brief Summary
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Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have been investigated and are now available for the management of constipation in PD. Preliminary data have suggested that probiotics could be help improving bowel habits but high-quality randomized trials are required in this area. Therefore, the investigators designed a randomized trial to evaluate whether the use of a fermented milk containing multiple probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD compared to placebo.

Official Title
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Double Blind, Placebo-controlled Trial of a Fermented Milk Containing Multiple Probiotics Strains and Prebiotic Fiber for Constipation Associated With Parkinson's Disease

Conditions
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Constipation

Intervention / Treatment
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* Other: Probiotics and prebiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of constipation according to Roma III criteria complete bowel movements per week <3 total bowel movements per week <6 written informed consent Exclusion Criteria: report of loose (mushy) or watery stool in the absence of laxative use ongoing artificial nutrition lactose intolerance chronic inflammatory bowel disease previous abdominal surgery use of anti-cholinergics use of antibiotics in the 6 weeks before baseline visit Radio- chemotherapy Cognitive decline (Mini Mental State Examination <27)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics and prebiotic<br>fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber | Other: Probiotics and prebiotic<br>* Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber<br>|
| Placebo Comparator: Placebo<br>pasteurized fermented milk (125 grams) without prebiotics | Other: Placebo<br>* Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete bowel movements | Change in the mean number of complete spontaneous bowel movements | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bowel movements | Change in the mean number of spontaneous bowel movements | 4 weeks | 
| Stool consistency | Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale) | 4 weeks | 
| Laxative use | Change in the mean use of laxative | 4 weeks | 
| Treatment satisfaction | Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale | 4 weeks | 
| Treatment continuation | Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale | 4 weeks | 
| Increase in one or more complete bowel movements | Percentage of patients reporting an increase in one or more complete bowel movements | 4 weeks | 
| Frequency of three or more complete bowel movements | Percentage of patients reporting three or more complete bowel movements | 4 weeks |