Based on the findings of a first clinical trial, which were recently published in the journal Digestive and Liver Disease, Health Canada has granted Lesaffre Human Care a new condition-specific claim for ibSium, the company’s unique strain of Saccharomyces cerevisiae CNCM I-3856. The newly approved claim is as follows: “Helps to reduce abdominal pain and discomfort associated with irritable bowel syndrome (IBS).”
ibSium has been exclusively licensed to Medical Futures Inc. (MFI), a wholly owned subsidiary of Tribute Pharmaceuticals Canada Inc., for the Canadian market. MFI will launch a finished product also called ibSium in Canada in the coming months.
Obtaining this new health claim is a big win for Lesaffre Human Care; it is a recognition of the company’s long-term investment in providing strong scientific and clinical data to substantiate the benefits of its patented strain of Saccharomyces cerevisiae in individuals with irritable bowel syndrome. The ingredient, also known on the market as Lynside Pro GI+ in certain countries, has demonstrated a significant effect in improving abdominal pain and discomfort in individuals with IBS, through:
Two clinical studies on a total of 600 volunteers with IBS and conducted by independent experts in Gastroenterology,
One consumer study implemented in collaboration with prescribing physicians on more than 1,160 volunteers presenting symptoms of IBS.
Sandrine Cuisenier, global marketing manager for Lesaffre Human Care, explained that “with millions of people worldwide affected by IBS, many of them unsatisfied with their current treatment, this claim approval will definitely have a positive impact on sales. It strengthens the position of our customers on the market by allowing end-users to better grasp the real benefits that ibSium could have on their quality of life. As an ingredient supplier, obtaining a strong label also builds trust and confidence in the quality of our products and the associated scientific research, a way for Lesaffre Human Care to reiterate its commitment to providing the highest level of service and product excellence.”
For people looking for a long-term strategy to manage their intestinal pain and discomfort, ibSium, now approved by Health Canada, will be soon available as an all-natural health solution in Canada, as it is already in some other countries. ibSium is a safe and effective new answer that helps to reduce abdominal pain and discomfort associated with irritable bowel syndrome, according to the company.