Trial of Probiotics for Constipation in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Probiotic Capsule; Drug: Placebo Capsule

• Registration Number: NCT03377322
• Lead Sponsor: University of Malaya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-19
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Probiotic Capsule	Probiotics capsules
Placebo	Placebo Capsule	Placebo capsules containing maltodextrin

Primary Outcome Measures

Name	Time	Method
Change in frequency of bowel opening per week	Week 4 post randomisation	Average number of bowel opening per week based on stool diary

Secondary Outcome Measures

Name	Time	Method
Change in patient's quality of life in relation to constipation	Week 4 post randomisation	Total score of PAC-QOL questionnaire (Marquis et al, Scandinavian J of Gastroenterology 2008). This scale has a total of 28 items evaluating four different constructs related to quality of life which include worries/concerns, physical discomfort, psychosocial discomfort and patient's satisfaction. Each item is scored from 1 to 5, with 5 indicating the worst severity.
Change in constipation severity score	Week 4 post randomisation	Total score of a constipation severity questionnaire adapted from ROME IV criteria for functional constipation. This scale evaluates the severity of five parameters related to constipation which include straining during defecation, lumpy or hard stools, sensation of incomplete evacuation, manual manoeuvres to facilitate defecations and spontaneous bowel movements per week. Each parameter is scored from 0 to 3, with 3 indicating the worst severity.
Change in stool consistency	Week 4 post randomisation	Average stool consistency based on Bristol stool chart that was included in the stool diary

Trial Locations

Locations (1)

University of Malaya; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia