Trial of Probiotics for Constipation in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03377322
• Other study ID #: ProbioRCT
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: October 2019
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Parkinson Disease

Intervention

Drug:
• Probiotic Capsule
Probiotic - one capsule a day for four weeks
• Placebo Capsule
Placebo - one capsule a day for four weeks

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of bowel opening per week	Average number of bowel opening per week based on stool diary	Week 4 post randomisation
Secondary	Change in stool consistency	Average stool consistency based on Bristol stool chart that was included in the stool diary	Week 4 post randomisation
Secondary	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
Secondary	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