Pre-biotics and Probiotics for Constipation in Parkinson's Disease
NCT ID: NCT02459717
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2015-06-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotics and prebiotic
fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
Probiotics and prebiotic
Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
Placebo
pasteurized fermented milk (125 grams) without prebiotics
Placebo
Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)
Interventions
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Probiotics and prebiotic
Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
Placebo
Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)
Eligibility Criteria
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Inclusion Criteria
* complete bowel movements per week \<3
* total bowel movements per week \<6
* written informed consent
Exclusion Criteria
* 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)
18 Years
90 Years
ALL
No
Sponsors
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Fondazione Mondino
OTHER
Istituti Clinici di Perfezionamento di Milano
OTHER
Emanuele Cereda
OTHER
Responsible Party
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Emanuele Cereda
Co-project Investigator
Principal Investigators
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Claudio Pacchetti, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Neurologico Mondino
Locations
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IRCCS Istituto Neurologico Mondino
Pavia, , Italy
Countries
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References
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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.
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.
Other Identifiers
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66/INT/2015
Identifier Type: -
Identifier Source: org_study_id
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