AXIM Biotechnologies has enrolled 40 patients with irritable bowel syndrome (IBS) and initiated a Phase 2 clinical trial evaluating the effectiveness of its CanChew Plus cannabinoid (CBD)-based chewing gum for alleviating IBS symptoms.
The announcement was made by Medical Marijuana, a U.S. publicly traded cannabis company.
The eight-week randomized, double-blind, placebo-controlled clinical trial (NCT03003260) will assessing whether CanChew chewing gum (50 mg of CBD per piece of gum) can improve IBS symptoms such as stomach cramps, bloating, pain, and other symptoms in 40 adults selected from a pool of over 400 patients.
Patients will be randomly assigned to receive up to six pieces of gum per day, containing either 50 mg of cannabidiol per piece in CanChew or a placebo chewing gum.
The primary outcome measure is pain reduction as perceived by patients. Other efficacy endpoints of the study include the assessment of the gum’s effectiveness in providing general relief to patients, and change in stool frequency.
The last patient is expected to be enrolled next month, and the study should be complete in June this year.
The study is being conducted by Renger Witkamp, professor and chair in nutrition and pharmacology at Wageningen University in the Netherlands.
“Successfully enrolling patients in this IBS clinical trial, which marks the first advancement in cannabinoid research for treatment of IBS in medical history, is an exciting new milestone for AXIM’s clinical development program,” Stuart Titus, Medical Marijuana’s CEO, said in a recent press release.
“With the global treatment market for IBS estimated to grow in value to $1.5 billion by 2023, AXIM’s efforts continue to push forward with cutting-edge solutions to help people suffering from some of the most common gastrointestinal disorders, not only for IBS, but for irritable bowel disease and ulcerative colitis as well,” he said.
CanChew Gum contains naturally occurring cannabidiol from the hemp plant and is rich in omega 3. CanChew gum does not contain any artificial sweeteners or any preservatives and does not require a medical prescription. It is available in all U.S. states.
AXIM Biotechnologies’ cannabinoid (CBD)-based products are also being tested in patients with multiple sclerosis (MS) to relieve pain and spasticity.
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