A Randomised, Double-blinded, Placebo-controlled Study of Kivia (Trademark) 575mg Zyactinase (Registered Trademark) Capsule for the Improvement of Digestive Health Parameters in Subjects with Irritable Bowel Syndrome with Constipation Symptoms

Irritable bowel syndrome (IBS) is the most common gastrointestinal disorder without any physical or physiological abnormality affecting approximately 10% of the population of Western countries. IBS is largely diagnosed in early adulthood and though the degree to which people are affected differs, IBS can cause significant impact of lifestyle, relationships and productivity. Kivia (Trademark) Zyactinase (Registered Trademark) is a 100% natural freeze-dried kiwifruit product which has been tested in both animals and humans and shown to be safe Kivia (Trademark) is manufactured in New Zealand and is commercially available in Australia. The purpose of this Phase III study is to see whether the product Kivia (Trademark) containing the active ingredient Zyactinase (Registered Trademark) can provide relief of IBS associated constipation and other symptoms of IBS. Subjects diagnosed with constipation dominant IBS will be randomised in a 1:1 ratio to receive either Kivia (Trademark) or matched placebo capsules for eight weeks Daily information about IBS-C symptoms will be captured by subjects using an electronic diary, and they will attend six clinic visits for efficacy and safety assessments.