Constipation
Conditions
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.
Interventions
OTHERProbiotics and prebiotic
Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
OTHERPlacebo
Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)
Sponsors
Fondazione Mondino
Istituti Clinici di Perfezionamento di Milano
Emanuele Cereda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete bowel movements | 4 weeks | Change in the mean number of complete spontaneous bowel movements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency | 4 weeks | Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale) |
| Laxative use | 4 weeks | Change in the mean use of laxative |
| Treatment satisfaction | 4 weeks | Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale |
| Number of bowel movements | 4 weeks | Change in the mean number of spontaneous bowel movements |
| Increase in one or more complete bowel movements | 4 weeks | Percentage of patients reporting an increase in one or more complete bowel movements |
| Frequency of three or more complete bowel movements | 4 weeks | Percentage of patients reporting three or more complete bowel movements |
| Treatment continuation | 4 weeks | Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale |
Countries
Italy
Outcome results
None listed