Phloe® the brand, is now proudly owned, marketed and distributed by Douglas Pharmaceuticals Ltd as of September 1st, 2015, for the New Zealand market. We will continue to sell Phloe in all our usual channels, such as pharmacy, grocery and healthfood stores. We also plan to continue selling Phloe online.
Please contact us if you should have any queries or issues:
Phone (9am to 4pm) 0800 622 533
For more information, please read the Media Release.
Press Release: Vital Foods Completes Recruitment for the IDEA Trial, a Phase 3 Trial of Zyactinase® in IBS-C
New Zealand natural pharmaceutical company Vital Food Processors Ltd announced the completion of patient enrolment for its IDEA Trial, a Phase 3 trial investigating the role of the company’s kiwifruit extract Zyactinase in alleviating the symptoms associated with Constipation-predominant Irritable Bowel Syndrome (IBS-C).
The 13-centre trial investigates the efficacy of Vital Foods’ proprietary and patented kiwifruit extract Zyactinase, marketed under the brand names Phloe® and Kivia®, in trial participants diagnosed with irritable bowel syndrome (IBS) with constipation.
The randomised, placebo-controlled, double-blinded Phase 3 clinical trial has recruited over 180 subjects who are treated over a three-month period. Recruitment has taken place at 13 sites across Australia and New Zealand.
The IDEA Trial is designed to build on the extensive platform of existing clinical and nonclinical research supporting the efficacy and safety of Zyactinase. Vital Foods’ chief executive Justus Homburg said: “This trial is designed to build on the results of previous studies that focussed on relief of constipation and showed that Kivia relieves abdominal bloating and pain in people with the symptoms generally associated with IBS.” IDEA Trial Principal Investigator Professor Peter Gibson of Melbourne’s Monash University and the Alfred Hospital, commented: “Kivia is an appealing therapy and it is very well tolerated and seems to have prolonged benefit. These observations need to be scientifically tested and that is what the IDEA Trial is designed to do.” University of Adelaide’s Professor Jane Andrews, the investigator managing the trial at the Royal Adelaide Hospital, added: “There’s such a lot of advertising of health claims for foods and supplements, it’s really refreshing to find a company prepared to put their product to the test in a properly designed clinical trial”.
Detailed final results of the IDEA trial are expected before the end of the year.
Zyactinase is a 100% natural product derived from New Zealand kiwifruit using Vital Foods’ proprietary processing technology with no artificial ingredients. Products formulated with Zyactinase, include Phloe and Kivia capsules and chewable tablets. Seven separate studies have confirmed that Zyactinase formulations support general digestive health and bowel function. Zyactinase formulations are well tolerated by the bowel.
About the IDEA Clinical Trial
The IDEA Trial is a Randomised, Double-blinded, Placebo-controlled Study of Kivia 575mg Zyactinase Capsule for the Improvement of Digestive Health Parameters in Subjects with Irritable Bowel Syndrome with Constipation Symptoms. The primary endpoint is determined by the overall responder rate for both increased weekly stool frequency of at least one complete spontaneous bowel movement (CSBM) AND decreased weekly average of worst abdominal pain of at least 30% from baseline using a Visual Analogue Scale (VAS) of 0-10 cm. This primary endpoint is consistent with the Food & Drug Administration (FDA) and the European Medicines Agency guidance on the design of IBS-C clinical trials. The new clinical study is a key step towards confirming Kivia as a treatment of a clinically diagnosed disease internationally, and in turn, growing opportunities in the global consumer healthcare market.