Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04451096
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2020-06-19
Brief Title:
Probiotics-prebiotic Fiber Therapy in Parkinsons Disease Patients With Constipation
Sponsor:
National University of Malaysia
Organization:
National University of Malaysia
Study Overview
Official Title:
Probiotics-prebiotic Fiber Therapy Improved Bowel Opening Frequency and Whole Gut Transit Time in Parkinsons Disease Patients With Constipation A Randomised Controlled Study
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics on constipation symptoms and whole gut transit time in patients with Parkinsons diseasePD patients with constipation were randomized to receive a multi-strain probiotic Lactobacillus spp and Bifidobacterium spp at 30 X 109 CFU with fructo-oligosaccaride FOS or placebo fermented milk twice daily for 8 weeks Primary outcomes include changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire GQ which included an item on bowel opening frequency Secondary and exploratory outcomes include whole gut transit time WGTT quality of life PDQ39-SI motor MDS-UPDRS and non-motor symptoms NMSS
Detailed Description:
This was an eight-week double-blind randomized placebo-controlled intervention study involving 55 idiopathic PD patients attending tertiary hospital This study was conducted in accordance with good clinical practice as per Declaration of Helsinki and was approved by the institutions Research and Ethics Committee FF-2018-387 Written informed consent was obtained from all particpants prior to enrollment
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 obstructionblockage for at least 25 of defecations
e Manual maneuvers to facilitate at least 25 of defecations eg 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 2130 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
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 obstructionblockage for at least 25 of defecations
e Manual maneuvers to facilitate at least 25 of defecations eg 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 2130 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None