Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With Constipation

Probiotics-prebiotic Fiber Therapy Improved Bowel Opening Frequency and Whole Gut Transit Time in Parkinson's Disease Patients With Constipation: A Randomised Controlled Study

Sponsors

Lead Sponsor: National University of Malaysia

Source National University of Malaysia
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 Parkinson's disease.PD 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 institution's 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 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.

Overall Status Completed
Start Date October 6, 2018
Completion Date February 28, 2019
Primary Completion Date February 28, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
constipation symptoms 8 weeks
Secondary Outcome
Measure Time Frame
Whole Gut Transit Time (WGTT) in hours 8 weeks
Frequency of patients with constipation (Bowel motion < 3 per week) in percentage 8 weeks
Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part 11 8 weeks
Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part 111 8 weeks
Non motor symptom score 8 weeks
Parkinsons Disease Quality of Life -39 Summary Index (PDQ39SI) 8 weeks
Weight in kilogram 8 weeks
Height in metres Baseline
Body Mass Index (kg/m2) 8 weeks
Enrollment 48
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Probiotics with prebiotic

Description: 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

Arm Group Label: Probiotic with prebiotic

Other Name: Multistrain Probiotics with prebiotic

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: 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

Arm Group Label: Placebo

Other Name: Granulated milk products

Eligibility

Criteria:

Inclusion Criteria:

- Age 18 or older; were diagnosed with idiopathic PD

- PD with Hoehn and Yahr stages 1-4,

- Fulfilled the Rome III criteria for functional constipation

Exclusion Criteria:

- MMSE score of ≤ 21/30

- 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Norlinah Mohamed Ibrahim, MBBChMRCP Principal Investigator National University of Malaysia
Location
Facility: Hospital Canselor Tuanku Muhriz, UKM Medical Center
Location Countries

Malaysia

Verification Date

June 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National University of Malaysia

Investigator Full Name: Dr Norlinah Mohamed Ibrahim

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Probiotic with prebiotic

Type: Active Comparator

Description: Drug: Probiotic sachet containing granulated multiple strains of Lactobacillus and Bifidobacterium, granulated fermented milk, lactose, fructo-oligosaccharide (FOS) with orange flavouring.

Label: Placebo

Type: Placebo Comparator

Description: Drug : Placebo sachet of granulated milk, lactose and orange flavouring, without FOS or microbial cells which appeared similar to the probiotics

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: placebo controlled

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: double blinded

Source: ClinicalTrials.gov