LAS VEGAS — A physician-formulated meal kit for colonoscopy preparation resulted in similar safety and effectiveness as standard bowel preparation regimens for colonoscopy, according to research presented at ACG 2016.
“Many patients of course find the current options for colon preparation unpleasant, poorly tolerated and difficult to complete,” Douglas K. Rex, MD, MACG, from Indiana University Hospital, said during his presentation. “About 40% of people who are eligible for screening don’t undergo the procedure and the most common reason given is the preparation, and that’s true not only for people who’ve had a colonoscopy, but for those who’ve never had a colonoscopy. So, advances are needed to develop a better tolerated preparation.”
Douglas K. Rex
Therefore, a company called ColonaryConcepts has developed edible colon preparations (ECP), which are physician-formulated meal kits consisting of food bars and shakes in which polyethylene glycol and electrolytes are embedded.
“The product was developed in collaboration with gastroenterologists, research chefs and human factors engineers to address the poor taste and monotony of existing preparations, the difficulty of fasting during the preparation and the negative experience of the preparation,” Rex said.
Previously, results from a pilot study were presented at DDW 2015, which showed excellent or good bowel cleansing in 10 out of 10 patients. The current phase 2 single blind, dual-center study sought to determine the best ECP formulation to advance to phase 3 trials.
Rex and colleagues randomly assigned colonoscopy patients to receive one of six different ECP formulations (n = 51; mean age, 61.5 years; 54% women) or two FDA approved active comparators (n = 14; comparable demographics). All patients had undergone prior colonoscopies so they could compare their preparation experiences.
The proportion of patients with excellent or good endoscopic visibility ratings on the Aronchick scale served as the primary endpoint.
The top three most effective ECP formulations resulted in excellent or good Aronchick ratings in 29 (90.6%) of 32 patients.
The lead formulation consists of three food bars, two shakes and three electrolyte drinks, with a total of 332 grams of PEG and a total volume of 1.8 liters. This formulation resulted in excellent or good ratings on the Aronchick scale in 93.3% of patients, with 88.9% of colon segments rated as excellent or good on the Ottawa scale.
The active comparators resulted in excellent or good Aronchick ratings 85.7% of the time.
No serious adverse events occurred. Moreover, 83.3% of patients who received the lead formulation said they were satisfied or extremely satisfied with the edible bowel prep compared with 30% of the comparators.
“ECP appears to be at least as effective and safe as currently available colonoscopy preparations,” Rex concluded. “Patients preferred ECP with high satisfaction. The phase 3 study is planned to begin in the first quarter of 2017.” – by Adam Leitenberger
Rex DK, et al. Abstract #11. Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 17-19, 2016; Las Vegas, NV.
Disclosures: Rex reports he is a consultant for ColonaryConcepts.