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Trial of Probiotics for Constipation in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03377322
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Tracking Information
First Submitted Date  ICMJE December 7, 2017
First Posted Date  ICMJE December 19, 2017
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE December 1, 2017
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
Change in frequency of bowel opening per week [ Time Frame: Week 4 post randomisation ]
Average number of bowel opening per week based on stool diary
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
Improvement in frequency of stool movements per week [ Time Frame: 4 weeks ]
Frequency of stool movements per week will be collected using a daily stool diary
Change History Complete list of historical versions of study NCT03377322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Change in stool consistency [ Time Frame: Week 4 post randomisation ]
    Average stool consistency based on Bristol stool chart that was included in the stool diary
  • Change in constipation severity score [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2017)
  • Improvement in constipation severity score [ Time Frame: 4 weeks ]
    Constipation severity score will be collected using a questionnaire adapted from ROME IV criteria for functional constipation
  • Improvement in patient's quality of life in relation to constipation [ Time Frame: 4 weeks ]
    Patient's quality of life in relation to constipation will be determined using the validated PAC QOL questionnaire
  • Improvement in stool consistency [ Time Frame: 4 weeks ]
    Stool consistency will be determined using the Bristol stool chart
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Probiotics for Constipation in Parkinson's Disease
Official Title  ICMJE A Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blinded
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: Probiotic Capsule
    Probiotic - one capsule a day for four weeks
  • Drug: Placebo Capsule
    Placebo - one capsule a day for four weeks
Study Arms  ICMJE
  • Active Comparator: Treatment
    Probiotics capsules
    Intervention: Drug: Probiotic Capsule
  • Placebo Comparator: Placebo
    Placebo capsules containing maltodextrin
    Intervention: Drug: Placebo Capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2019)
72
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2017)
60
Actual Study Completion Date  ICMJE January 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03377322
Other Study ID Numbers  ICMJE ProbioRCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Malaya
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ai Huey Tan, MD,FRCP University of Malaya
PRS Account University of Malaya
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP