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

Double Blind, Placebo-controlled Trial of a Fermented Milk Containing Multiple Probiotics Strains and Prebiotic Fiber for Constipation Associated With Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Other: Probiotics and prebiotic; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy
    • IRCCS Istituto Neurologico Mondino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics and prebiotic; fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber	Other: Probiotics and prebiotic; Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
Placebo Comparator: Placebo; pasteurized fermented milk (125 grams) without prebiotics	Other: Placebo; Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete bowel movements	Change in the mean number of complete spontaneous bowel movements	4 weeks

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Emanuele Cereda
• Collaborators: IRCCS Istituto Neurologico Mondino, Pavia, Italy; Istituti Clinici di Perfezionamento di Milano
• Investigators: Principal Investigator: Claudio Pacchetti, MD, IRCCS Istituto Neurologico Mondino

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Constipation
• Other Study ID Numbers: 66/INT/2015