Hemp CBD Gum Headed for Clinical Trial on Irritable Bowel Syndrome

Photo © iStockphoto.com/AlenaPaulus 

A controlled-realease hemp CBD (cannabidiol) chewing gum will be the subject of a new human clinical trial investigating the gum’s effects on alleviating symptoms of irritable bowel syndrome (IBS). Axim Biotechnologies (New York) announced this week that its CanChew Plus CBD gum has received approval from the Medical Ethical Committee of Wageningen University (The Netherlands) to move forward with a “first-of-its-kind” IBS study on 40 patients aged 18–85.

“CBD has been shown to help patients with numerous conditions and AXIM plans to explores these areas with their product pipeline,” George Anastassov, MD, CEO of Axim Biotechnologies, tells Nutritional Outlook. “IBS was one area of interest to capitalize on first as there is not an effective treatment on the market now, and about 10%–15% of the world population suffers from IBS.”

While there has been some research¹ into CBD for IBS in the past, this study is “groundbreaking” because it is the first of its kind to reach the stage of a clinical trial, according to Anastassov. It comes on the heels of positive pharmacokinetic/pharmacodynamics (PK/PD) data on CanChew Plus, which found that volunteers who chewed the gum for 30 minutes showed excellent bioavailability of CBD, with results suggesting “faster and higher uptake of CBD through our chewing gum compared to smoking and oral administration,” Anastassov says, in a press announcement. The PK/PD data included single-doses of either 10 mg of CBD or 30 mg of CBD.

The upcoming clinical trial will include participants diagnosed with IBS according to ROME III criteria, who will consume either CanChew Plus or matching placebo gums. The CBD gum will contain 50 mg of CBD, with participants directed to take up to six pieces of gum per day to help control bloating, pain, stomach cramps, and other symptoms of IBS. Researchers will assess efficacy based on pain reduction, general relief, and changes in stool frequency.

CanChew Plus will be a pharmaceutical product, and if this upcoming clinical trial yields a positive income, Axim Biotech plants to proceed with additional trials on pharmaceutical-grade CanChewRx products for IBS, ulcerative colitis, and Crohn’s disease.

Read more:

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Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com

References:

1.     Esposito G et al., “Cannabidiol in inflammatory bowel diseases: a brief overview,” Phytotherapy Research, vol. 27, no. 5 (May 2013): 633–636