Parkinson Disease
Conditions
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.
Interventions
Probiotic - one capsule a day for four weeks
DRUGPlacebo Capsule
Placebo - one capsule a day for four weeks
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded
Intervention model description
Placebo Controlled
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in frequency of bowel opening per week | Week 4 post randomisation | Average number of bowel opening per week based on stool diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool consistency | Week 4 post randomisation | Average stool consistency based on Bristol stool chart that was included in the stool diary |
| 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 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. |
Countries
Malaysia
Outcome results
None listed