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Trial registered on ANZCTR


Registration number
ACTRN12619001204134
Ethics application status
Approved
Date submitted
14/08/2019
Date registered
28/08/2019
Date last updated
28/08/2019
Date data sharing statement initially provided
28/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of KFibre in heartburn
Scientific title
Efficacy of Kfibre™ in combating Gastroesophageal Reflux Disease
Preliminary Human Clinical Study
Secondary ID [1] 299012 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastro-esophageal Reflux Disease 314021 0
Acid Reflux disease 314022 0
Heartburn 314023 0
Condition category
Condition code
Oral and Gastrointestinal 312411 312411 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
Approach:
In order to test an alternative GERD treatment, a clinical trial will be conducted using K-fibreTM compared to a placebo of insoluble crystalline cellulose. This is a food grade fibre (Agri Food Ingredients (N G Alexander & Co Pty Ltd) Suite 15, 828 High St. Kew East VIC 3102; www.agrifi.com.au) and is used as a food fibre as well as an excipient in the manufacture of pills. The study will be conducted in Launceston by doctors in association with gastric clinics. A Research Associate will be employed to undertake the organisation of the trials and collection and collation of results.
Patients will be assigned into Treatment Groups. The study will be double blind with neither the patient or the Doctor and staff administering the study knowing which people are receiving the treatment or placebo control.
All patients will be given a 150 gm container of test insoluble fibre or placebo with instructions on use. Patients will be instructed to stir one heaped teaspoon into a glass of water in the morning after food in the morning and night, to drink it immediately in suspended form. After 3 weeks treatment patients will return to the Clinic for assessment and be requested to return the unused portion of the fibre to validate consumption. Patients should continue to administer the dose until assessed by the GP.
Timetable:
Group 1: K-fibre (3g/day; twice daily) and Group2: cellulose placebo (3g/day; twice daily)
Day 1: Informed consent- Age, sex, smoking status, medical history, BMI and vital signs.
At enrolment validated GERD-HRQL questionnaire will be administered by the participating GP. It has both composite score plus individual symptoms assessment (nine questions reported in a scale of 0 to 5). The overall score will be a maximum of 75 (the higher the score, the more the severity of GERD). The total time required to administer the questionnaire would be 1-2 minutes. The questionnaire has been designed to get specific data about heartburn through heartburn score (maximum of 30) and regurgitation through regurgitation score (maximum 30).
Day 20: After 3 weeks treatment the validated GERD-HRQL questionnaire will be administered again by the participating GP.
After 3 weeks, the intervention will be discontinued completely.
Strategy to monitor adherence: container returns to measure any left over samples
Intervention code [1] 315290 0
Treatment: Other
Comparator / control treatment
Patients will be assigned into Treatment Groups. The study will be double blind with neither the patient or the Doctor and staff administering the study knowing which people are receiving the treatment or placebo control.
All patients will be given a 150 gm container of test insoluble fibre or placebo with instructions on use. Patients will be instructed to stir one heaped teaspoon into a glass of water in the morning after food in the morning and night, to drink it immediately in suspended form. After 3 weeks treatment patients will return to the Clinic for assessment and be requested to return the unused portion of the fibre to validate consumption. Patients should continue to administer the dose until assessed by the GP.
Timetable:
Group2: cellulose placebo (3g/day; twice daily)
Day 1: Informed consent- Age, sex, smoking status, medical history, BMI and vital signs.
At enrolment validated GERD-HRQL questionnaire will be administered by the participating GP. It has both composite score plus individual symptoms assessment (nine questions reported in a scale of 0 to 5). The overall score will be a maximum of 75 (the higher the score, the more the severity of GERD). The total time required to administer the questionnaire would be 1-2 minutes. The questionnaire has been designed to get specific data about heartburn through heartburn score (maximum of 30) and regurgitation through regurgitation score (maximum 30).
Day 20: After 3 weeks treatment the validated GERD-HRQL questionnaire will be administered again by the participating GP.
Control group
Placebo

Outcomes
Primary outcome [1] 321069 0
The only outcome of this study is GERD-HRQL questionnaire. as an assessing tool for heartburn symptoms.
At enrolment validated GERD-HRQL questionnaire will be administered by the participating GP. It has both composite score plus individual symptoms assessment (nine questions reported in a scale of 0 to 5). The overall score will be a maximum of 75 (the higher the score, the more the severity of GERD). The total time required to administer the questionnaire would be 1-2 minutes. The questionnaire has been designed to get specific data about heartburn through heartburn score (maximum of 30) and regurgitation through regurgitation score (maximum 30).
Timepoint [1] 321069 0


Day1: At enrolment validated GERD-HRQL questionnaire will be administered by the participating GP
Day 21: After 3 weeks treatment the validated GERD-HRQL questionnaire will be administered again by the participating GP.
Secondary outcome [1] 373875 0
Nil
Timepoint [1] 373875 0
Nil

Eligibility
Key inclusion criteria
Inclusion Criteria:
• Male or Female
• Ages 18-75
• Heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization.
• Able to read, understand, and complete study questionnaires and record
• Able to understand the study procedures and sign informed consent
• Able to comply with all study requirements
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
• Subjects with Barrett's esophagus, non-erosive reflux disease, EE grades A or B, or peptic stricture on endoscopy
• Subjects with previous upper gastrointestinal surgery
• Subjects with clinically significant underlying comorbidity
• Helicobacter pylori positive
• Clinically significant GI bleed within the last 3 months
• Esophagitis not related to acid reflux
• Bleeding disorder
• Zollinger-Ellison, achalasia, esophageal varices, duodenal/gastric ulcer, upper gastrointestinal malignancy
• Women pregnant or lactating

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All results will be expressed as means ± SD. Statistical test will include unpaired student t-test or Mann-Whitney U test, with p<0.05 regarded as significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/06/2019
Date of last participant enrolment
Anticipated
20/09/2019
Actual
Date of last data collection
Anticipated
10/10/2019
Actual
Sample size
Target
40
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 27564 0
7250 - Newstead

Funding & Sponsors
Funding source category [1] 303547 0
Commercial sector/Industry
Name [1] 303547 0
KFSU PTY LTD
Country [1] 303547 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
PO Box 1322, Launceston, TAS 7250
Country
Australia
Secondary sponsor category [1] 303635 0
None
Name [1] 303635 0
Address [1] 303635 0
Country [1] 303635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304077 0
The Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 304077 0
Ethics committee country [1] 304077 0
Australia
Date submitted for ethics approval [1] 304077 0
23/01/2018
Approval date [1] 304077 0
13/09/2018
Ethics approval number [1] 304077 0
H0017109

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95738 0
A/Prof RAJARAMAN ERI
Address 95738 0
School of Health Sciences
University of Tasmania
Locked Bag 1320
Launceston
TAS 7250
Country 95738 0
Australia
Phone 95738 0
+61363245467
Fax 95738 0
+61363242222
Email 95738 0
rderi@utas.edu.au
Contact person for public queries
Name 95739 0
RAJARAMAN ERI
Address 95739 0
School of Health Sciences
University of Tasmania
Locked Bag 1320
Launceston
TAS 7250
Country 95739 0
Australia
Phone 95739 0
+61363245467
Fax 95739 0
+61363242222
Email 95739 0
rderi@utas.edu.au
Contact person for scientific queries
Name 95740 0
RAJARAMAN ERI
Address 95740 0
School of Health Sciences
University of Tasmania
Locked Bag 1320
Launceston
TAS 7250
Country 95740 0
Australia
Phone 95740 0
+61363245467
Fax 95740 0
+61363242222
Email 95740 0
rderi@utas.edu.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?



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.