Indigestion & Acid Reflux

Acid Reflux or Gastro-Oesophageal Reflux (GOR) is a condition suffered by many individuals at some point in their lives, with some estimates suggesting 60-70% of the population suffering from reflux in any 12-month period.

Informal observations of HFS customers indicated that Kfibre was effective in modifying symptoms in acid reflux/ gastroesophageal reflux. There are no similar reports of insoluble prebiotic fibre being effective for relief of symptoms. Gastroesophageal reflux disease (GERD) is a condition that affects around 20% of Australians and causes drastic reduction in quality of life. GERD is symptomatically referred to as heartburn or reflux disease because the acidic stomach content travels backwards towards the oesophagus and the feeling of acidity is the major symptom. There is a large body of evidence to indicate significant morbidity associated with GERD. These include lack of quality sleep, dysphagia, and oesophageal cancer in severe cases. Current treatment for GERD mainly consists of proton pump Inhibitors (PPI). While PPI work well in over half of the GERD patients, there is a refractory group (30%) that needs effective alternative therapies.

Patients were assigned into Treatment Groups. The study was double blind with neither the patient or the Doctor and staff administering the study knowing which people are receiving the treatment or placebo control.

At enrolment, a validated GERD-HRQL questionnaire was be administered by the participating GP. It has both composite scores 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).

After 3 weeks treatment the validated GERD-HRQL questionnaire was administered again by the participating GP. At the completion of all participants in the trial, the research team analysed the GERD-HRQL questionnaire data and correlated treatments against symptom scores.

Results

At the conclusion of the study the research team analysed the GERD-HRQL questionnaire data and correlated treatments against symptom scores.

Heartburn score for Kfibre (Pre vs Post treatment)
(Lower is better)
Available on publication

Regurgitation score for Kfibre (Pre vs Post treatment)
(Lower is better)
Available on publication

Data: Placebo vs Kfibre (PSCF)
Available on publication

This world-first study, ”Anti-heartburn effects of sugar cane flour: A double-blind, randomised, placebo-controlled study”, investigating the efficacy of Kfibre to ameliorate acid reflux/GERD symptoms shows a considerable clinical benefit in reducing the acid reflux/GERD symptoms compared to a placebo intervention. This is a pilot study with 40 subjects (20 subjects in each group) with the treatment group prescribed Kfibre for a period of only 3 weeks. The results clearly show an excellent reduction and trend towards symptom alleviation in the Kfibre treated subjects compared to the placebo group. In clinical terms, these results are extremely valuable.

Summary & Future direction

The study has shown significant benefit of Kfibre supplementation for reducing acid reflux and regurgitation symptoms. Sugar cane whole plant fibre used in the study was well tolerated and showed symptom alleviation within 3 weeks. While the exact mechanism is not fully understood, the clinical benefit indicatively demonstrated warrants a larger multi-centre randomised controlled trial with dose escalation and longer duration intervention.

Patent

Patent Application (#2014349787) “Dietary Supplement for the treatment of acid reflux and gastro- oesophageal reflux disease (GORD/GERD)”

Summary of the invention
According to an aspect of the invention, there is provided a method of treatment of the chronic and acute effects of Acid reflux or GORD/GERD over an extended period in an individual by feeding to said individual a food product incorporating dietary fibre material extracted from sugar cane.

Links

a. “Anti-heartburn effects of sugar cane flour (Kfibre): A double-blind, randomised, placebo-controlled study”

b. Neeraj Kumar Singh, Jeff Beckett (Help in trial, statistics, writing), Jehan Phillips, Krishna Kalpurath (Clinicians), Kent Taylor (KFSU), Roger Stanley, Raj Eri (Primary investigators)

c. Publishing soon – World Journal of Gastroenterology

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