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

Primary Purpose

Constipation

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Probiotics and prebiotic

Placebo

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

IRCCS Istituto Neurologico Mondino

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics and prebiotic

Placebo

Arm Description

fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber

pasteurized fermented milk (125 grams) without prebiotics

Outcomes

Primary Outcome Measures

Complete bowel movements

Change in the mean number of complete spontaneous bowel movements

Secondary Outcome Measures

Number of bowel movements

Change in the mean number of spontaneous bowel movements

Stool consistency

Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale)

Laxative use

Change in the mean use of laxative

Treatment satisfaction

Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale

Treatment continuation

Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale

Increase in one or more complete bowel movements

Percentage of patients reporting an increase in one or more complete bowel movements

Frequency of three or more complete bowel movements

Percentage of patients reporting three or more complete bowel movements

Full Information

NCT ID

NCT02459717

First Posted

May 26, 2015

Last Updated

October 1, 2015

Sponsor

Emanuele Cereda

Collaborators

IRCCS Istituto Neurologico Mondino, Pavia, Italy, Istituti Clinici di Perfezionamento di Milano

1. Study Identification

Unique Protocol Identification Number

NCT02459717

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Emanuele Cereda

Collaborators

IRCCS Istituto Neurologico Mondino, Pavia, Italy, Istituti Clinici di Perfezionamento di Milano

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotics and prebiotic

Arm Type

Experimental

Arm Description

fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

pasteurized fermented milk (125 grams) without prebiotics

Intervention Type

Other

Intervention Name(s)

Probiotics and prebiotic

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete bowel movements

Description

Change in the mean number of complete spontaneous bowel movements

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Number of bowel movements

Description

Change in the mean number of spontaneous bowel movements

Time Frame

4 weeks

Title

Stool consistency

Description

Change in mean stool consistency (scored with the use of the 7-point Bristol Stool Form Scale)

Time Frame

4 weeks

Title

Laxative use

Description

Change in the mean use of laxative

Time Frame

4 weeks

Title

Treatment satisfaction

Description

Satisfaction with the trial medication's ability to relieve constipation symptoms as assessed by a self-rating scale

Time Frame

4 weeks

Title

Treatment continuation

Description

Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale

Time Frame

4 weeks

Title

Increase in one or more complete bowel movements

Description

Percentage of patients reporting an increase in one or more complete bowel movements

Time Frame

4 weeks

Title

Frequency of three or more complete bowel movements

Description

Percentage of patients reporting three or more complete bowel movements

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudio Pacchetti, MD

Organizational Affiliation

IRCCS Istituto Neurologico Mondino

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS Istituto Neurologico Mondino

City

Pavia

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

27543643

Citation

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.

Results Reference

derived

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

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