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Completed

NCT Number: NCT03377322

Trial of Probiotics for Constipation in Parkinson's Disease

This is a double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics in the treatment of constipation in Parkinson's disease.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya

Kuala Lumpur, 59100, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Capsule

Drug

Probiotic - one capsule a day for four weeks

Placebo capsule

Drug

Placebo - one capsule a day for four weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2017
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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