Trial of Probiotics for Constipation in Parkinson's Disease

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

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Probiotic Capsule
* Drug: Placebo Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo Controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Probiotics capsules | Drug: Probiotic Capsule<br>* Probiotic - one capsule a day for four weeks<br>|
| Placebo Comparator: Placebo<br>Placebo capsules containing maltodextrin | Drug: Placebo Capsule<br>* Placebo - one capsule a day for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of bowel opening per week | Average number of bowel opening per week based on stool diary | Week 4 post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stool consistency | Average stool consistency based on Bristol stool chart that was included in the stool diary | Week 4 post randomisation | 
| Change in constipation severity score | 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. | Week 4 post randomisation | 
| Change in patient's quality of life in relation to constipation | 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. | Week 4 post randomisation |