Parkinson DiseaseNCT03377322
Trial of Probiotics for Constipation in Parkinson's Disease
A study testing Probiotic Capsule in people with Parkinson Disease, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Probiotic Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2017to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-Blinded Placebo-Controlled 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.
- Conditions
- Parkinson Disease
- Being tested
- Probiotic Capsule, Placebo Capsule
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic CapsuleDrug
Probiotic - one capsule a day for four weeks
Placebo CapsuleDrug
Placebo - one capsule a day for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Probiotics capsules Receives: Drug: Probiotic Capsule |
| Placebo | Placebo comparator | Placebo capsules containing maltodextrin Receives: Drug: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of bowel opening per week
Average number of bowel opening per week based on stool diary
Measured: Week 4 post randomisation
Secondary outcomes (3)
Change in stool consistency
Average stool consistency based on Bristol stool chart that was included in the stool diary
Measured: Week 4 post randomisation
Change in constipation severity score
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.
Measured: Week 4 post randomisation
Change in patient's quality of life in relation to constipation
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.
Measured: Week 4 post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Dec 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ai Huey Tan, MD,FRCP, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377322
- Sponsor's protocol ID
- ProbioRCT
- Status last verified
- Oct 2019
- First submitted
- 7 Dec 2017
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39470206Tan 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.
PubMed 33046607
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03377322
- Acronym / sponsor ID
- ProbioRCT
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics in the treatment of constipation in Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Probiotic CapsuleProbiotics capsules |
| Placebo | Placebo comparator | Drug: Placebo CapsulePlacebo capsules containing maltodextrin |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic CapsuleProbiotic - one capsule a day for four weeks | Drug | Treatment |
| Placebo CapsulePlacebo - one capsule a day for four weeks | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
Change in stool consistency
Time frame: Week 4 post randomisation
Change in constipation severity score
Time frame: Week 4 post randomisation
Change in patient's quality of life in relation to constipation
Time frame: Week 4 post randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Derived from this study: PubMed 39470206Todd 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.
- Derived from this study: PubMed 33046607Tan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ai Huey Tan, MD,FRCP principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Capsule in people with Parkinson Disease, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of bowel opening per week (time frame: Week 4 post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377322, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.