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Trial of Probiotics for Constipation in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03377322
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : October 31, 2018
Information provided by (Responsible Party):
University of Malaya

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Probiotic Agent Drug: Placebo oral capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: A Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's Disease
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Treatment
Probiotic Agent contains Bifidobacterium lactis
Drug: Probiotic Agent
Probiotic - one capsule a day for four weeks

Placebo Comparator: Placebo
Placebo pill containing maltodextrin
Drug: Placebo oral capsule
Placebo - one capsule a day for four weeks

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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. 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.

  2. 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 (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.

  3. Improvement in stool consistency [ Time Frame: 4 weeks ]
    Stool consistency will be determined using the Bristol stool chart

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03377322

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Contact: Ai Huey Tan 60379492891
Contact: Kah Kian Chong 60379492891

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University of Malaya Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Contact: Ai Huey Tan, MD(UKM), MRCP(UK)   
Sponsors and Collaborators
University of Malaya

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Responsible Party: University of Malaya Identifier: NCT03377322     History of Changes
Other Study ID Numbers: ProbioRCT
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Signs and Symptoms, Digestive
Signs and Symptoms