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Trial registered on ANZCTR
Registration number
ACTRN12625000813482p
Ethics application status
Submitted, not yet approved
Date submitted
7/07/2025
Date registered
30/07/2025
Date last updated
30/07/2025
Date data sharing statement initially provided
30/07/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The effects of FloraSMART on gastrointestinal symptoms and health in older adults
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Scientific title
Randomised controlled trial assessing the effects of FloraSMART A17 blend on gastrointestinal symptoms and health in older adults
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Secondary ID [1]
314831
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal symptoms: Constipation
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Irregular Bowel habits
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Gastrointestinal symptoms: Abdominal Pain
338290
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Gastrointestinal symptoms: Diarrhoea
338291
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Gastrointestinal symptoms: Indigestion
338292
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Condition category
Condition code
Oral and Gastrointestinal
334396
334396
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0
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Normal oral and gastrointestinal development and function
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
One capsule (20 mg) of FloraSMART A17 blend postbiotic (includes 17 mg of the tyndallized bacteria; Lactobacillus casei subsp. casei 327; Lactobacillus paracasei K71; Enterococcus faecalis EC-12; Bifidobacterium longum BR-108) sweet potato starch, tapioca starch. consumed at the same time each day for 6 weeks.
Participants will be contacted each fortnight to record whether they have missed any doses or altered timing of the dose. Participants will visit the Murdoch University Physiology lab following 6 weeks of supplementation, during which they will be asked to return the bottle containing the supplements. The number of supplements remaining will be counted to determine compliance to the supplementation schedule. Participants who consume 80% or more of the study product will be considered adherent and included in the per-protocol analysis.
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Intervention code [1]
331436
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Treatment: Other
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Comparator / control treatment
One capsule (20 mg) of maltodextrin consumed at the same time each day for 6 weeks.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Gastrointestinal symptoms: Composite score
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Assessment method [1]
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Gastrointestinal symptom scale (GSRS): - Change in the mean aggregate score for four symptom clusters (abdominal pain, indigestion, diarrhoea, constipation).
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Timepoint [1]
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Baseline; 2 weeks, 4 weeks and 6 weeks (primary timepoint) after first dose.
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Primary outcome [2]
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Bowel habits: Stool Consistency
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Assessment method [2]
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Bowel habits questionnaire: Bristol stool form
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Timepoint [2]
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baseline; 2, 4 and 6 weeks (primary timepoint) after first dose.
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Secondary outcome [1]
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Health-related quality of life
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Assessment method [1]
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36-Item Short Form Health Survey questionnaire (SF-36)
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Timepoint [1]
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baseline and week 6 after first dose.
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Secondary outcome [2]
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Sleep quality
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Assessment method [2]
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Pittsburgh Sleep Quality Index
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Timepoint [2]
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Baseline and week 6 after first dose.
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Secondary outcome [3]
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Mood
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Assessment method [3]
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Profile of Mood States
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Timepoint [3]
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Baseline and week 6 after first dose
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Secondary outcome [4]
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Mood
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Assessment method [4]
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The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
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Timepoint [4]
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Baseline and week 6 after first dose
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Secondary outcome [5]
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Sleepiness
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Assessment method [5]
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Epworth Sleepiness Scale
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Timepoint [5]
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Baseline and week 6 after first dose
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Secondary outcome [6]
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Fatigue
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Assessment method [6]
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Fatigue Assessment Scale
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Timepoint [6]
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Baseline and week 6 after first dose.
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Secondary outcome [7]
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Body mass index
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Assessment method [7]
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Height (measured in metres using a stadiometer) and weight (measured in kilograms using an electronic digital platform weighing scale): Formula (BMI = weight/height/height)
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Timepoint [7]
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Baseline and week 6 after first dose.
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Secondary outcome [8]
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Whole Body composition
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Assessment method [8]
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Dual energy x-ray absorptiometer
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Timepoint [8]
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Baseline and week 6 after first dose.
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Secondary outcome [9]
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Blood pressure
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Assessment method [9]
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Electronic blood pressure cuff
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Timepoint [9]
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baseline and week 6 after first dose.
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Secondary outcome [10]
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Gastrointestinal symptoms: Abdominal pain
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Assessment method [10]
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Gastrointestinal symptom scale (GSRS): Change in abdominal pain.
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Timepoint [10]
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Baseline; 2 weeks, 4 weeks and 6 weeks after first dose.
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Secondary outcome [11]
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Gastrointestinal symptoms: Change in indigestion.
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Assessment method [11]
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Gastrointestinal symptom scale (GSRS): Change in indigestion score
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Timepoint [11]
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Baseline; 2 weeks, 4 weeks and 6 weeks after first dose.
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Secondary outcome [12]
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Gastrointestinal symptoms: Change in diarrhoea
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Assessment method [12]
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Gastrointestinal symptom scale (GSRS): Change in diarrhoea.
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Timepoint [12]
450198
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Baseline; 2 weeks, 4 weeks and 6 weeks after first dose.
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Secondary outcome [13]
450199
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Gastrointestinal symptoms: Change in constipation.
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Assessment method [13]
450199
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Gastrointestinal symptom scale (GSRS): Change in constipation.
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Timepoint [13]
450199
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Baseline; 2 weeks, 4 weeks and 6 weeks after first dose.
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Secondary outcome [14]
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Stool frequency
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Assessment method [14]
450200
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Self reported (diary): number of weekly bowel movements
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Timepoint [14]
450200
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Baseline; 2 weeks, 4 weeks and 6 weeks after first dose.
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Eligibility
Key inclusion criteria
1) Aged 60-80 years old
2) Community dwelling
3) Willing and able to comply with the protocol and participate for the planned duration of the study.
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Minimum age
60
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1) Taking 3 or more prescription medications
2) Received oral or parenteral antibiotics during the 28 days before the baseline visit
3) Hospitalization, major surgery or endoscopy within the last 3 months or scheduled hospital admission with 3 months of enrolment.
4) Known allergy to probiotics, Lactobacillus, Bifidobacterium, Enterococcus, antibiotics that could be used to treat Lactobacillus/ Bifidobacterium infection, microcrystalline cellulose or gelatin.
5) Serious gastrointestinal illness including chronic liver disease, gastrointestinal surgery, cancer, inflammatory bowel disease, pancreatitis or motility disorder in the last 2 years.
6) Current use of pro-/pre-/post-biotics
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (n=2, 4 6) using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
18/08/2025
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Actual
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Date of last participant enrolment
Anticipated
27/10/2025
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Actual
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Date of last data collection
Anticipated
8/12/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
319391
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Commercial sector/Industry
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Name [1]
319391
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Anderson Advanced Ingredients
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Address [1]
319391
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Country [1]
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United States of America
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Primary sponsor type
University
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Name
Murdoch University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
321877
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Address [1]
321877
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Country [1]
321877
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317965
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Murdoch University Human Research Ethics Committee
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Ethics committee address [1]
317965
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http://our.murdoch.edu.au/Research-Ethics-and-Integrity/Human-research-ethics
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Ethics committee country [1]
317965
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Australia
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Date submitted for ethics approval [1]
317965
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15/01/2025
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Approval date [1]
317965
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Ethics approval number [1]
317965
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Summary
Brief summary
The composition, diversity, and function of gut bacteria collectively referred to as the gut microbiome undergo notable changes with ageing. These changes can have significant impacts on overall health. For example, ageing is associated with an increased abundance of potentially harmful bacteria, such as Enterobacteriaceae, while certain beneficial bacteria such as Bifidobacterium often decline. These shifts can contribute to chronic low-grade inflammation and adverse health outcomes. The gut microbiome can be influenced through the use of supplements called prebiotics, probiotics and postbiotics. Multiple health benefits have been reported in response to supplementation with postbiotics in adults, however, most of the existing work has been done in assessing the health benefits in young adults, with very few studies specifically targeting older adults. The aim of this study is to identify whether supplementation with FloraSMART A17 blend reduces gastrointestinal symptoms and improves quality of life in older adults.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Timothy Fairchild
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Address
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Murdoch University, 90 South Street, Murdoch WA 6150
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Country
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Australia
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Phone
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+61 8 9360 2959
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Timothy Fairchild
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Address
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Murdoch University, 90 South Street, Murdoch WA 6150
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Country
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Australia
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Phone
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+61 8 9360 6000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Timothy Fairchild
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Address
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Murdoch University, 90 South Street, Murdoch WA 6150
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Country
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Australia
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Phone
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+61 8 9360 2959
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Fax
142712
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Email
142712
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Anyone
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
What individual participant data might be shared?
•
De-identified individual participant data:
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All outcomes data
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Published results
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Safety data
What types of analyses could be done with individual participant data?
•
Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of:
15
years
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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