Comvita Limited announced very promising preliminary results of its first Feasibility Clinical Trial, known as SOOTHE, that examined the impact of Comvita Lepteridine™ Mānuka Honey treatment on digestive health.
The SOOTHE Trial follows positive pre-clinical research, undertaken by Comvita and researchers at The University of Auckland, showing that Lepteridine™, a natural compound found uniquely in Mānuka Honey and nectar, inhibits a key biological pathway known to be implicated in a range of inflammatory digestive conditions. This research led to Comvita patenting novel formulations of Lepteridine™ Mānuka Honey which were used in the SOOTHE trial.
Whilst many consumers report using Mānuka Honey to support their digestive health, science has not yet fully understood the mechanisms of action behind this effect. Co-funded by The High-Value Nutrition (HVN) National Science Challenge and Comvita, and undertaken by the University of Otago and its partners, The Riddet Institute and the Malaghan Institute of Medical Research, this groundbreaking $1.4 million randomised, double-blind, placebo-controlled, feasibility Clinical Trial was designed to help researchers answer this question.
Dr. Jackie Evans, Chief Science Officer at Comvita was excited by the findings and the potential to change the way people with digestive health conditions could be treated in the future.
“This Clinical Trial, the first of its kind, shows that Lepteridine™ Mānuka Honey can significantly improve digestive symptom response in people with Functional Dyspepsia, a common digestive condition with limited effective treatment options characterised by stomach symptoms including heartburn, pain, and discomfort.”
Results show that 50% more people treated with Lepteridine™ Mānuka Honey experienced a meaningful improvement in their symptoms, compared with placebo.
“In addition, there was also a noticeable dose response, with 71% of subjects treated with the highest dose of Lepteridine™ Mānuka Honey reporting more than a 40% improvement in their symptoms,” Dr Evans concluded, who co-presented the findings at Foodomics 2024 in Wellington.
The SOOTHE Trial’s Co-Principal Investigator, Professor Nicole Roy, Research Professor in the Department of Human Nutrition, University of Otago and HVN Digestive Health Science Theme Leader, commented that these results provide key insights that will help design future clinical trials.
“Feasibility clinical trials, such as this SOOTHE Clinical Trial, are an essential step for scientifically proving the health benefits of nutrition interventions, they help us narrow down what’s important and what isn’t for designing future studies. In addition to the preliminary results presented today, we are also undertaking additional analyses looking at blood inflammatory markers that may be important outcomes in this population.”
Another of the Trial’s Investigators, Professor Richard Gearry, Professor of Medicine, University of Otago, and Consultant Gastroenterologist at Christchurch Hospital, noted
“The preliminary results of this study are encouraging and help us to determine which outcomes are the most meaningful and guide us on appropriate design for future research in people with Functional Dyspepsia. The significant symptom response seen in this Trial shows that this is an important outcome and points to the potential of Lepteridine™ Mānuka Honey as a promising treatment option for patients suffering from inflammatory digestive conditions.”
Comvita is advancing its scientific research programme on Lepteridine™ Mānuka Honey and planning for further clinical trials is already underway. Dr Evans is looking forward to further research.
“Building on these initial positive findings we believe that Comvita Lepteridine™ Mānuka Honey has the potential to redefine digestive health treatment options and help millions of people worldwide,” Dr Evans concluded.
Article reproduced with permission from Comvita Limited.