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Trial of Probiotics for Constipation in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Probiotic Capsule
Placebo Capsule
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Malaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Probiotics capsules

Placebo capsules containing maltodextrin

Outcomes

Primary Outcome Measures

Change in frequency of bowel opening per week
Average number of bowel opening per week based on stool diary

Secondary Outcome Measures

Change in stool consistency
Average stool consistency based on Bristol stool chart that was included in the stool diary
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.
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.

Full Information

First Posted
December 7, 2017
Last Updated
October 28, 2019
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT03377322
Brief Title
Trial of Probiotics for Constipation in Parkinson's Disease
Official Title
A Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Placebo Controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Probiotics capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules containing maltodextrin
Intervention Type
Drug
Intervention Name(s)
Probiotic Capsule
Intervention Description
Probiotic - one capsule a day for four weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Capsule
Intervention Description
Placebo - one capsule a day for four weeks
Primary Outcome Measure Information:
Title
Change in frequency of bowel opening per week
Description
Average number of bowel opening per week based on stool diary
Time Frame
Week 4 post randomisation
Secondary Outcome Measure Information:
Title
Change in stool consistency
Description
Average stool consistency based on Bristol stool chart that was included in the stool diary
Time Frame
Week 4 post randomisation
Title
Change in constipation severity score
Description
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.
Time Frame
Week 4 post randomisation
Title
Change in patient's quality of life in relation to constipation
Description
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.
Time Frame
Week 4 post randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai Huey Tan, MD,FRCP
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33046607
Citation
Tan AH, Lim SY, Chong KK, A Manap MAA, Hor JW, Lim JL, Low SC, Chong CW, Mahadeva S, Lang AE. Probiotics for Constipation in Parkinson Disease: A Randomized Placebo-Controlled Study. Neurology. 2021 Feb 2;96(5):e772-e782. doi: 10.1212/WNL.0000000000010998. Epub 2020 Oct 12.
Results Reference
derived

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Trial of Probiotics for Constipation in Parkinson's Disease

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