Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001247965
Ethics application status
Approved
Date submitted
24/09/2020
Date registered
20/11/2020
Date last updated
15/10/2021
Date data sharing statement initially provided
20/11/2020
Date results information initially provided
15/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a novel prebiotic in adults with mild constipation
Scientific title
A randomised, single-blinded, controlled trial of a novel prebiotic formulation; assessing changes in stool frequency in adults with mild constipation
Secondary ID [1] 302223 0
Nil known
Universal Trial Number (UTN)
U1111-1257-8418
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 318918 0
Gastrointestinal health 318919 0
Condition category
Condition code
Oral and Gastrointestinal 316899 316899 0 0
Normal oral and gastrointestinal development and function
Oral and Gastrointestinal 317437 317437 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prebiotic multi-ingredient formulation: A novel prebiotic powder containing partially hydrolysed guar gum, red dragon fruit extract, acacia gum, slippery elm, cacao extract and pectin.
Dose - 6 g twice daily (total of 12 g/day) mixed with 150 mL of water
Duration - 3 weeks
Mode of administration - oral, powder
Intervention compliance will be assessed by measurement of weight of returned product.
Intervention code [1] 318670 0
Treatment: Other
Comparator / control treatment
Control: A capsule with 1% acacia gum and 99% maltodextrin.
Dose - 1 capsule once daily (total of 500 mg) taken with 150 mL of water
Duration - 3 weeks
Mode of administration - oral, capsule
Intervention compliance will be assessed by counting number of returned capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 325219 0
Change in stool output frequency, measured as complete spontaneous bowel motions (CSBM)
Timepoint [1] 325219 0
From baseline to 3 weeks post intervention commencement, assessed weekly through structured interview at days 7, 14 and 21.
Secondary outcome [1] 387237 0
Changes in bowel movement consistency (Bristol Stool Chart)
Timepoint [1] 387237 0
From baseline to 3 weeks post intervention commencement, assessed weekly through structured interview at days 7, 14 and 21.
Secondary outcome [2] 387238 0
Change in symptoms of constipation assessed by the Patient Assessment of Constipation Symptoms (PAC-SYM)
Timepoint [2] 387238 0
Assessed at baseline and at 3 weeks post intervention commencement.
Secondary outcome [3] 387239 0
Changes to the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire
Timepoint [3] 387239 0
Assessed at baseline and at 3 weeks post intervention commencement.
Secondary outcome [4] 387240 0
Changes to QOL assessed by the Depression, Anxiety, Stress Scale-21 (DASS-21)
Timepoint [4] 387240 0
Assessed at baseline and at 3 weeks post intervention commencement.
Secondary outcome [5] 387241 0
Change in gastrointestinal microbial population assessed using complete metagenomic sequencing of the bacterial 16S ribosomal gene present in the fecal sample
Timepoint [5] 387241 0
Assessed at baseline and at 3 weeks post intervention commencement.
Secondary outcome [6] 387242 0
Change in gastrointestinal microbial diversity index assessed using complete metagenomic sequencing of the bacterial 16S ribosomal gene present in the fecal sample
Timepoint [6] 387242 0
Assessed at baseline and at 3 weeks post intervention commencement.
Secondary outcome [7] 387243 0
Change in gastrointestinal microbial metabolite potential production assessed using complete metagenomic sequencing of the bacterial 16S ribosomal gene present in the fecal sample
Timepoint [7] 387243 0
Assessed at baseline and at 3 weeks post intervention commencement.

Eligibility
Key inclusion criteria
Participants meeting with following criteria to be included in the study:
- Male and females aged 25 to 45 years.
- Participants who can provide informed consent.
- Consumption of less than 4 serves of vegetables, fruit and wholegrains combined per day on average.
- 1-4 stools/week on average (complete spontaneous bowel motion).
- BMI < 18.5 < 35.
Minimum age
25 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting with following criteria to be excluded from the study:
- Any clinically relevant abnormal findings which, in the opinion of the investigators/clinicians, may put participant at risk of adverse events including: Physical examination; Clinical chemistry; Haematology; Vital signs
- History of diagnosis of gastrointestinal disease, inflammatory bowel disease, or functional
gastrointestinal disorders, previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery) or experiencing dysphagia
- Systemic lupus erythematosus, cancer, thyroid disease, renal disease, hepatic disease, or uncontrolled metabolic disease
- Individuals taking probiotics, antibiotics, fibre supplements, antacids, proton pump inhibitors, stool softeners or laxatives at time of recruitment or within the previous four weeks
- Has any allergies or past reactions to ingredients in treatment and placebo, including acacia gum, guar gum or maltodextrin
- Women only) Pregnancy or nursing of an infant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be allocated to one of two treatment arms through a random draw of opaque envelopes. Product allocation will be carried out by personnel not involved in study analysis. A code will be allocated and recorded to the product and the participant which will not be disclosed to the investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted on an intention to treat (ITT) population basis. Data will be analysed using SPSS software (IBM, USA). Depending upon normality test and resultant distribution, data is expected to be either parametric (age, weight, height, body mass index (BMI), blood pressure, stool frequency and characteristics, validated questionnaires) and laboratory clinical parameters) or non-parametric (gender and lifestyle parameters, validated questionnaires, diet analysis and microbiome analysis).
Demographic parameters (age, weight, height, BMI and blood pressure) will be measured by unpaired t-tests. Gender and lifestyle parameters will be analyzed by two-sided Fisher’s Exact test for proportion. Primary outcome of CSBM will be evaluated at four independent time-points (baseline, week 1, week 2, week 3) using a repeated-measures ANOVA. For all questionnaire assessments (PAC-SYM, PAC-QOL, DASS-21), effectiveness of both treatment groups will be compared as the change in group means (SD) from baseline to
study completion (paired t-tests). The laboratory clinical parameters data will be analysed using unpaired t-tests. A p-value <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/11/2020
Date of last participant enrolment
Anticipated
30/04/2021
Actual
7/01/2021
Date of last data collection
Anticipated
21/05/2021
Actual
29/01/2021
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 31374 0
4005 - New Farm

Funding & Sponsors
Funding source category [1] 306646 0
Commercial sector/Industry
Name [1] 306646 0
Integria Healthcare (Australia) Pty Ltd.
Country [1] 306646 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Integria Healthcare (Australia) Pty Ltd.
Address
Building 5, 2728 Logan Road (Cnr School Rd),
Freeway Office Park, Eight Mile Plains QLD 4113
Country
Australia
Secondary sponsor category [1] 307195 0
None
Name [1] 307195 0
Address [1] 307195 0
Country [1] 307195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306828 0
National Institute of Integrative Medicine
Ethics committee address [1] 306828 0
Suite 6, Riverwalk One, 140 Robina Town Centre Dr, Robina QLD 4226
Ethics committee country [1] 306828 0
Australia
Date submitted for ethics approval [1] 306828 0
24/08/2020
Approval date [1] 306828 0
13/10/2020
Ethics approval number [1] 306828 0
0075E_2020

Summary
Brief summary
A novel prebiotic product, targeted for microbiome modulation in patients with low levels
of fibre intake and those prone to constipation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105154 0
Dr Elizabeth Steels
Address 105154 0
Evidence Sciences Pty Ltd.
Clinic: 4/884 Brunswick Street, New Farm 4005 QLD
Registered Office: 188 James Street, New Farm, 4005 QLD
Country 105154 0
Australia
Phone 105154 0
+61 0431 003 929
Fax 105154 0
Email 105154 0
drbeth@evidencesciences.com.au
Contact person for public queries
Name 105155 0
Dr Elizabeth Steels
Address 105155 0
Evidence Sciences Pty Ltd.
Clinic: 4/884 Brunswick Street, New Farm 4005 QLD
Registered Office: 188 James Street, New Farm, 4005 QLD
Country 105155 0
Australia
Phone 105155 0
+61 0431 003 929
Fax 105155 0
Email 105155 0
drbeth@evidencesciences.com.au
Contact person for scientific queries
Name 105156 0
Dr Elizabeth Steels
Address 105156 0
Evidence Sciences Pty Ltd.
Clinic: 4/884 Brunswick Street, New Farm 4005 QLD
Registered Office: 188 James Street, New Farm, 4005 QLD
Country 105156 0
Australia
Phone 105156 0
+61 0431 003 929
Fax 105156 0
Email 105156 0
drbeth@evidencesciences.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.