New clinical trial will look at role of kiwifruit extract in IBS
New Zealand natural pharmaceutical company Vital Food Processors Ltd today announced the launch of a trans-Tasman
clinical trial targeting treatment of irritable bowel syndrome.
The 10-centre trial will investigate the efficacy of the kiwifruit extract Kivia in patients diagnosed with irritable
bowel syndrome (IBS) with constipation.
Vital Foods already markets the same product under the brand name Phloe in the over-the-counter market in New Zealand.
Irritable bowel syndrome is regarded as a major women’s health issue affecting about one in 10 people, mostly women aged
between 20 and 50 years. There are limited treatment options for the condition, which presents as recurring abdominal
pain or discomfort associated with either constipation or diarrhoea that lasts for at least six months.
The double-blind, randomised, placebo-controlled Phase III clinical trial, to establish the efficacy of Kivia, will
recruit 180 patients who will be monitored and treated over a three-month period. Recruitment will take place at 10
sites across New Zealand and Australia. Patients are already being admitted to the trial in Auckland, Melbourne, Sydney,
Brisbane, and Adelaide. Two other New Zealand centres will start recruiting patients this month. Results are expected
before the end of this year and if successful, will lead to entry of the product into international markets with a
specific health indication for the treatment of IBS.
Vital Foods’ chief executive Justus Homburg said Phloe is one of the most extensively investigated natural products for
digestive health.
“This clinical trial is designed to build on the results of previous studies that focussed on relief of constipation and
showed that Phloe relieved abdominal bloating, pain and flatulence in people with some of the symptoms also associated
with IBS,” said Mr Homburg. “These included four randomised, double-blind, placebo-controlled trials conducted in the
United States and in China and three randomised open-label trials conducted in Japan.”
Gastroenterologist Dr Alasdair Patrick, who is managing the trial site at Auckland’s MacMurray Centre, says the new
study is a significant step in identifying a successful treatment for the estimated 2.7 million people in New Zealand
and Australia that suffer from IBS.
“Dietary intervention is already a mainstay of our treatment of IBS. Adjusting the intake of fibre, carbohydrate and fat
in the diet can be effective, but IBS remains difficult to treat and is an ongoing burden for many people that impacts
on their daily quality of life. This trial is a step towards identifying an effective treatment.”
Dr Iona Weir, Vital Foods’ chief scientific officer, says international investigations into the cause of IBS to date
have yielded no clear results.
“However, while the causes of IBS have not been clearly identified, we do know what factors can contribute to symptoms.
In earlier studies, Phloe has been shown to relieve some of those symptoms and what is most exciting is that it appears
the proprietary kiwifruit extract in the product, zyactinase, may actually modify some of the contributing factors in
the gut.
“We now have an extensive body of clinical data that supports the efficacy of Phloe.”
Anyone who is interested in further information about this clinical trial or who is interested in participating in the
trial should go to: www.theideastudy.com
About IBS
Irritable Bowel Syndrome is a chronic gastrointestinal disorder estimated to affect between 9 and 23% of the population
worldwide. Although it affects approximately one in 10 people, the International Federation for Functional
Gastrointestinal Disorders reports that most IBS sufferers do not seek medical help. Nevertheless, in the United States
between 2.4 and 3.5 million annual physician visits are for patients diagnosed with IBS, and it has become a major
women’s health issue.
About Phloe
One of the most effective, gentle laxative over-the-counter therapies currently available, Phloe is made from green
kiwifruit using Vital Foods’ proprietary processing technology. Studies have confirmed that Phloe improves general
digestive health, minimises episodes of occasional constipation, and assists in reducing abdominal discomfort. Phloe has
few, if any, of the side effects commonly associated with harsher laxatives. It has been recently made a standard
preparation for many patients undergoing radiation therapy for prostate and bowel cancer in New Zealand.
About Kivia
Kivia is the same formulation as Phloe but, if this trial confirms expected efficacy, it will be marketed
internationally with a specific claim for treatment of IBS.
About Vital Foods
Vital Foods’ was established to provide the digestive health benefits of kiwifruit through easy to consume digestive
health products for all ages. The company’s first product on the market was Kiwi Crush, a frozen kiwifruit drink that is
sold as a digestive aid in supermarkets in New Zealand. Research into its therapeutic effects led to the development of
Phloe, also based on kiwifruit, which was launched in 2007 and is now available in pharmacy, healthfood and grocery
outlets in New Zealand and is about to be launched globally through www.digestivephloe.com . Together, the two products currently make up the highest-selling digestive health product family sold in New Zealand.
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.
In mid 2011 Nestle took at 18.2% stake in the company through its wholly-owned Health Sciences Company. Other
shareholders are New Zealand’s largest kiwifruit company Seeka Kiwifruit Industries, the venture funds BioPacific
Ventures and Inventages, and private interests.
ENDS