None listed
Conditions
Brief summary
K-fibreTM is produced in Australia by KFSU Ltd from sugar cane as a whole cane product. Informal observations of KFSU customers indicated that of K-fibreTM was effective in controlling of symptoms in heartburn or gastroesophageal reflux disease (GERD). Gastroesophageal reflux disease (GERD) is a condition that affects around 20% Australians and causes drastic reduction in quality of life.This preliminary human clinical study is proposed with a hypothesis that KFibre will reduce/control gastroesophageal reflux disease and associated heartburn or indigestion symptoms.
Interventions
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 w
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
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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
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
Outcome results
None listed