NCT03377322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

1.2 years

First QC Date

December 7, 2017

Last Update Submit

October 28, 2019

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Change in frequency of bowel opening per week

    Average number of bowel opening per week based on stool diary

    Week 4 post randomisation

Secondary Outcomes (3)

  • Change in stool consistency

    Week 4 post randomisation

  • Change in constipation severity score

    Week 4 post randomisation

  • Change in patient's quality of life in relation to constipation

    Week 4 post randomisation

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Probiotics capsules

Drug: Probiotic Capsule

Placebo

PLACEBO COMPARATOR

Placebo capsules containing maltodextrin

Drug: Placebo Capsule

Interventions

Probiotic CapsuleDRUG

Probiotic - one capsule a day for four weeks

Treatment
Placebo CapsuleDRUG

Placebo - one capsule a day for four weeks

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (2)

  • Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.

    PMID: 39470206DERIVED

  • 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.

    PMID: 33046607DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ai Huey Tan, MD,FRCP

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Placebo Controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 19, 2017

Study Start

December 1, 2017

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)