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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. Read our disclaimer for details. Identifier: NCT03377322
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : October 30, 2019
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 Capsule Drug: Placebo Capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 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
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Treatment
Probiotics capsules
Drug: Probiotic Capsule
Probiotic - one capsule a day for four weeks

Placebo Comparator: Placebo
Placebo capsules containing maltodextrin
Drug: Placebo Capsule
Placebo - one capsule a day for four weeks

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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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University of Malaya
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
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Principal Investigator: Ai Huey Tan, MD,FRCP University of Malaya
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Responsible Party: University of Malaya Identifier: NCT03377322    
Other Study ID Numbers: ProbioRCT
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
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