Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With Constipation
NCT ID: NCT04451096
Last Updated: 2020-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2018-10-06
2019-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants were included if they were aged 18 or older; were diagnosed with idiopathic PD in Hoehn and Yahr stages 1-4, and fulfilled the Rome III criteria for functional constipation which requires the presence of recurrent abdominal pain 3 days per month in the last 3 months, and symptom onset 6 months prior to diagnosis, with additional criteria below to be fulfilled, as adapted from Longstreth, et al12.
1. Must include two or more of the following:
1. Straining during at least 25% of defecations
2. Lumpy or hard stools in at least 25% of defecations
3. Sensation of incomplete evacuation for at least 25% of defecations d. Sensation of anorectal obstruction/blockage for at least 25% of defecations
e. Manual maneuvers to facilitate at least 25% of defecations (e.g, digital evacuation, support of the pelvic floor) f. Fewer than 3 defecations per week
2. Loose stools are rarely present without the use of laxatives
3. There are insufficient criteria for IBS
Participants were excluded if they had: a MMSE score of ≤ 21/30; a positive stool occult blood screening; a diagnosis of secondary parkinsonism; previous history of small and large bowel disease; prior history of gastrointestinal tract surgery; use of probiotics or antibiotics two weeks prior to baseline visit; been on medications such as antidepressants or anticholinergics; history of lactose intolerance; concomitant diagnosis of hypothyroidism and diabetes mellitus.
All participants were assessed at baseline and at 8 weeks following intervention for all outcome assessments. At baseline, additional data on demographics (age, sex, educational level), duration of PD, dopaminergic medication, Hoehn \& Yahr Scoring during ON period, and the level of physical activity were recorded at baseline. A sedentary behaviour was defined as being physically active \< 4 hours /week.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Probiotic with prebiotic
Drug: Probiotic sachet containing granulated multiple strains of Lactobacillus and Bifidobacterium, granulated fermented milk, lactose, fructo-oligosaccharide (FOS) with orange flavouring.
Probiotics with prebiotic
Patients were instructed to consume one sachet twice daily mixed with a glass of water, before or after meals, for a duration of 8 weeks
Placebo
Drug : Placebo sachet of granulated milk, lactose and orange flavouring, without FOS or microbial cells which appeared similar to the probiotics
Placebo
Patients were instructed to consume one sachet twice daily mixed with a glass of water, before or after meals, for a duration of 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probiotics with prebiotic
Patients were instructed to consume one sachet twice daily mixed with a glass of water, before or after meals, for a duration of 8 weeks
Placebo
Patients were instructed to consume one sachet twice daily mixed with a glass of water, before or after meals, for a duration of 8 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* PD with Hoehn and Yahr stages 1-4,
* Fulfilled the Rome III criteria for functional constipation
Exclusion Criteria
* Positive stool occult blood screening
* Diagnosis of secondary parkinsonism
* Previous history of small and large bowel disease
* History of gastrointestinal tract surgery
* Use of probiotics or antibiotics two weeks prior to baseline visit
* Been on medications such as antidepressants or anticholinergics
* History of lactose intolerance
* Concomitant diagnosis of hypothyroidism and diabetes mellitus.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National University of Malaysia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Norlinah Mohamed Ibrahim
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Norlinah Mohamed Ibrahim, MBBChMRCP
Role: PRINCIPAL_INVESTIGATOR
National University of Malaysia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Canselor Tuanku Muhriz, UKM Medical Center
Kuala Lumpur, , Malaysia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FF-2018-387
Identifier Type: -
Identifier Source: org_study_id