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

NCT02459717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Probiotics and prebiotic

Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber

OTHER

Placebo

Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)

Sponsors & Collaborators

  • Fondazione Mondino

    collaborator OTHER

  • Istituti Clinici di Perfezionamento di Milano

    collaborator OTHER

  • Emanuele Cereda

    lead OTHER

Principal Investigators

  • Claudio Pacchetti, MD · IRCCS Istituto Neurologico Mondino

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459717 on ClinicalTrials.gov