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

Emanuele Cereda120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Constipation

Interventions

Probiotics and prebioticOTHER

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

IRCCS Istituto Neurologico Mondino

Pavia, Italy

Outcomes

Primary Outcomes

Complete bowel movements

Change in the mean number of complete spontaneous bowel movements

Time frame: 4 weeks

Secondary Outcomes

Number of bowel movements

Change in the mean number of spontaneous bowel movements

Time frame: 4 weeks

Stool consistency

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

Time frame: 4 weeks

Laxative use

Change in the mean use of laxative

Time frame: 4 weeks

Treatment satisfaction

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

Time frame: 4 weeks

Treatment continuation

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

Time frame: 4 weeks

Increase in one or more complete bowel movements

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

Time frame: 4 weeks

Frequency of three or more complete bowel movements

Percentage of patients reporting three or more complete bowel movements

Time frame: 4 weeks

Data from ClinicalTrials.gov

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