A Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's Disease

University of Malaya1 site in 1 country72 target enrollmentDecember 1, 2017

ConditionsParkinson Disease

InterventionsProbiotic Capsule Placebo Capsule

DrugsProbiotic Capsule Placebo Capsule

Overview

Phase: Not Applicable
Intervention: Probiotic Capsule
Conditions: Parkinson Disease
Sponsor: University of Malaya
Enrollment: 72
Locations: 1
Primary Endpoint: Change in frequency of bowel opening per week
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics in the treatment of constipation in Parkinson's disease.

Registry

clinicaltrials.gov

Start Date

December 1, 2017

End Date

January 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Malaya

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 50 to 80 years old
•Provision of written informed consent
•Diagnosis of PD made by a Neurologist using UK Brain Bank Criteria
•Fulfils criteria for functional constipation according to the Rome IV Criteria during in the preceding 6 months with frequency of bowel movements less than 3 times per week

Exclusion Criteria

•Ingestion of probiotics in the preceding 4 weeks
•Use of antibiotics in the preceding 4 weeks
•History of gastrointestinal disorders or surgery
•Known or suspected allergy to probiotics
•Comorbidities that prevent reliable completion of study assessments
•Prior functional neurosurgery for PD or treatment with apomorphine infusion
•Recent initiation of dopaminergic medications in the preceding 3 months

Arms & Interventions

Treatment

Probiotics capsules

Intervention: Probiotic Capsule

Placebo

Placebo capsules containing maltodextrin

Intervention: Placebo Capsule

Outcomes

Primary Outcomes

Change in frequency of bowel opening per week

Time Frame: Week 4 post randomisation

Average number of bowel opening per week based on stool diary

Secondary Outcomes

Change in patient's quality of life in relation to constipation(Week 4 post randomisation)
Change in constipation severity score(Week 4 post randomisation)
Change in stool consistency(Week 4 post randomisation)