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| Name | Class |
|---|---|
| IRCCS National Neurological Institute "C. Mondino" Foundation | OTHER |
| Istituti Clinici di Perfezionamento di Milano | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics and prebiotic | Experimental | fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber |
|
| Placebo | Placebo Comparator | pasteurized fermented milk (125 grams) without prebiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics and prebiotic | Other | Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete bowel movements | Change in the mean number of complete spontaneous bowel movements | 4 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Pacchetti, MD | IRCCS Istituto Neurologico Mondino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Neurologico Mondino | Pavia | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39470206 | Derived | Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6. | |
| 27543643 | Derived |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Other | Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics) |
|
| 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 |
| Barichella M, Pacchetti C, Bolliri C, Cassani E, Iorio L, Pusani C, Pinelli G, Privitera G, Cesari I, Faierman SA, Caccialanza R, Pezzoli G, Cereda E. Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT. Neurology. 2016 Sep 20;87(12):1274-80. doi: 10.1212/WNL.0000000000003127. Epub 2016 Aug 19. |
| D019602 |
| Food and Beverages |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |