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Parkinson DiseasePhase 3NCT04451096

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

A Phase 3 study testing Probiotics with prebiotic in people with Parkinson Disease and Constipation, run by National University of Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Constipation
What is being tested?
Probiotics with prebiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteMalaysia
Study dates
6 Oct 2018to 28 Feb 2019
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Been on medications such as antidepressants or anticholinergics
  • History of lactose intolerance
  • Concomitant diagnosis of hypothyroidism and diabetes mellitus.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Hospital Canselor Tuanku Muhriz, UKM Medical Center

    Kuala Lumpur, 56000

Other trials in Malaysia

About this study

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

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).

Read the 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:
  2. Straining during at least 25% of defecations
  3. Lumpy or hard stools in at least 25% of defecations
  4. Sensation of incomplete evacuation for at least 25% of defecations d. Sensation of anorectal obstruction/blockage for at least 25% of defecations
  5. 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
  6. Loose stools are rarely present without the use of laxatives
  7. 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.

Being tested
Probiotics with prebiotic, Placebo
Keywords
Parkinson's disease, Constipation, Probiotics, Prebiotic, Gut transit time, Motor outcome, NMSS, PDQ39, Randomised controlled trial
Medical subject headings
Parkinson Disease, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotics with prebioticDietary supplement

    Also called Multistrain 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

  • PlaceboDietary supplement

    Also called Granulated milk products

    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

Study groups in NCT04451096
Study groupRoleWhat they receive
Probiotic with prebioticActive comparatorDrug: Probiotic sachet containing granulated multiple strains of Lactobacillus and Bifidobacterium, granulated fermented milk, lactose, fructo-oligosaccharide (FOS) with orange flavouring.
Receives: Dietary Supplement: Probiotics with prebiotic
PlaceboPlacebo comparatorDrug : Placebo sachet of granulated milk, lactose and orange flavouring, without FOS or microbial cells which appeared similar to the probiotics
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. constipation symptoms

    The presence of constipation symptoms at baseline and at 8 weeks evaluated by

    Garrigues Questionnaire (GQ).GQ is a 21-item self-reported screening questionnaire to detect the presence of constipation symptoms, using two different sets of four-point Likert scale responses.Although 12 items assess bowel habits, 9 items specifically assess constipation symptoms and were used in our evaluation: (i)Feeling of blockage in the anus;(ii) Need to press around anus/vagina to complete bowel movement; (iii) Spend >10 minutes to pass stool;(iv) Straining during bowel movement;(v) Feeling of hard stool;(vi) Feeling of incomplete emptying sensation; (vii)Bowel opening frequency;(viii) Frequency of oral laxative use;(ix) Frequency of enema use

    Measured: 8 weeks

Secondary outcomes (9)

  1. Whole Gut Transit Time (WGTT) in hours

    WGTT was measured at baseline and at the end of 8 weeks, using red carmine capsule. The mean change in the WGTT (WGTT 8 weeks - WGTT baseline) was compared between the two groups.

    Measured: 8 weeks

  2. Frequency of patients with constipation (Bowel motion < 3 per week) in percentage

    Based on the stool diary, the percentage of patients who experienced less than 3 BM per week was calculated at baseline and at the end of study.

    Measured: 8 weeks

  3. Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part 11

    This measures the motor aspects of activity of daily living and consists of 13 items with scores between 0- 52. This instrument is given at baseline and 8 weeks. Lower score indicates low severity

    Measured: 8 weeks

  4. Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part 111

    This measures the seveirty of motor symptoms using 18 items (score 0-72). This instrument is given at baseline and 8 weeks. Lower score indicates low severity.

    Measured: 8 weeks

  5. Non motor symptom score

    Change in non-motor symptoms severity scores using the Non motor Symptom Scale (NMSS) which consists of 9 domains (cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucination, attention/memory, gastrointestinal tract, urinary, sexual function and miscellaneous.Score ranges from minimum of 3 to 360. Lower score indicates lower severity

    Measured: 8 weeks

  6. Parkinsons Disease Quality of Life -39 Summary Index (PDQ39SI)

    Change in PD9 39-SI which measure 8 domains of Quality of Life ( Lower score indicates better quality of life)

    Measured: 8 weeks

  7. Weight in kilogram

    Change in body weight measurement in Kg

    Measured: 8 weeks

  8. Height in metres

    Height will be measured in meters at baseline

    Measured: Baseline

  9. Body Mass Index (kg/m2)

    Weight and height will be combined to report BMI in kg/m^

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start6 Oct 2018
  3. Primary completion28 Feb 2019
  4. Study completion28 Feb 2019

Resources

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 3
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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451096
Sponsor's protocol ID
FF-2018-387
Status last verified
Jun 2020
First submitted
19 Jun 2020
Last updated
30 Jun 2020
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 39470206

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Probiotics with prebiotic in people with Parkinson Disease and Constipation, run by National University of Malaysia 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 3 inclusion and 9 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 Jun 2020. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

constipation symptoms (time frame: 8 weeks). 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 NCT04451096, which also lists 1 linked publication.

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 Jun 2020.

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