Double Blind, Placebo-controlled Trial of a Fermented Milk Containing Multiple Probiotics Strains and Prebiotic Fiber for Constipation Associated With Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Constipation
- Sponsor
- Emanuele Cereda
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Complete bowel movements
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Emanuele Cereda
Co-project Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Complete bowel movements
Time Frame: 4 weeks
Change in the mean number of complete spontaneous bowel movements
Secondary Outcomes
- Stool consistency(4 weeks)
- Number of bowel movements(4 weeks)
- Treatment satisfaction(4 weeks)
- Frequency of three or more complete bowel movements(4 weeks)
- Laxative use(4 weeks)
- Treatment continuation(4 weeks)
- Increase in one or more complete bowel movements(4 weeks)