Edible Bowel Prep Pleases Patients
http://www.medscape.com/viewarticle/870470
LAS VEGAS — An edible bowel preparation successfully delivers polyethylene glycol (PEG) and electrolytes prior to colonoscopy, and was highly rated by patients in a randomized phase 2 trial.
"Many patients find the current options for colon preparation unpleasant, poorly tolerated, and difficult to complete. Advances are needed to develop a better-tolerated preparation," said investigator Douglas Rex, MD, from Indiana University Hospital in Indianapolis.
Bowel prep tops the list of reasons that approximately 40% of people eligible for colonoscopy screening do not undergo the procedure, he said here at the American College of Gastroenterology 2016 Annual Scientific Meeting.
The edible colonoscopy preparation meal kit from ColonaryConcepts is being developed by a different kind of multidisciplinary team: gastroenterologists, research chefs, and human-factors engineers. A pilot study presented at Digestive Disease Week 2015 revealed excellent or good cleansing in 10 of 10 patients.
In their dual-center, single-blind study, Dr Rex and his colleagues looked at six edible colon prep formulations — with different PEG and electrolyte doses and different meal kit items — to identify which formulation should proceed to phase 3 studies.
Fifty-one participants were randomly assigned to edible colon prep and 14 were assigned to a standard prep with either MoviPrep from Salix Pharmaceuticals or GoLYTELY from Braintree Laboratories.
Participants ranged in age from 40 to 75 years, 59% were women, and 94% were white.
Endoscopic Visibility
The primary outcome — an endoscopic visibility rating of good to excellent on the Aronchick Scale — was achieved by 93% of patients who received the top-rated edible prep formulation.
Secondary assessments included segment-by-segment visibility, safety, tolerability, and patient satisfaction. Physicians rated 89% of the segments as good or excellent on the Ottawa Bowel Preparation Scale.
All participants had undergone a previous colonoscopy so they could compare the experiences.
More patients in the edible-prep group than in the standard-prep group reported being satisfied or extremely satisfied with the process (64% vs 33%). However, a few participants preferred their previous preparation or saw no difference, Dr Rex reported.
The top-rated edible formulation, determined after a series of comparisons, consisted of three food bars (lemon, white chocolate, and coconut) and two shakes (vanilla and strawberry–banana), which delivered 332 grams of PEG 3350, and three drinks (one orange and two mixed berry), which delivered electrolytes.
Some of the edible formulations assessed contained items like soup and chicken with rice, but they were excluded from the analysis.
Food Bars, Shakes, and Drinks
All of the edible components contain USP national formulary ingredients, so the prep will be marketed as a drug kit. Patients will be instructed to consume five individual color-coded meals: a noon lunch, 3 pm snack, 6 pm dinner, 8 pm snack, and 7 am breakfast. The one shake taken on the morning of colonoscopy makes this a split preparation.
"The edible colonoscopy preparation appears to be at least as effective and safe as currently available colonoscopy preparations," Dr Rex said.
There were no significant laboratory or vital sign abnormalities, no serious adverse events, and no unexpected serious adverse reactions with the edible prep, he reported. Typical adverse events with standard bowel prep include nausea, vomiting, burning, and soreness.
We all know that the worst part of the procedure is the bowel prep.
"Edible prep could represent a major advance in our ability to screen patients with colonoscopy, because we all know that the worst part of the procedure is the bowel prep," said session comoderator Mark Pochapin, MD, from the NYU Langone Medical Center in New York City.
"The preliminary data are very exciting, and a prep that is more palatable may improve the overall experience of a colonoscopy," he told Medscape Medical News.
"We all know the potential life-saving aspects of colonoscopy, and a better-tolerated prep could help us increase the number of patients screened," he added.
"This is a low-volume prep," Dr Rex responded when session comoderator Elena Stoffel, MD, from the University of Michigan in Ann Arbor, asked whether there are populations the edible prep is not suitable for. "There will always be patients who require a more aggressive preparation," he said.
Dr Stoffel also asked about the use of edible prep for patients with diabetes.
"That is unclear at this time" because diabetic patients were excluded from the study, Dr Rex explained. "We will need more information to know how it will do in obese patients, diabetics, and patients with some predictors of failed prep."
A phase 3 study is planned for the first quarter of 2017.
Dr Rex is a consultant for ColonaryConcepts. Dr Pochapin and Dr Stoffel have disclosed no relevant financial relationships.
American College of Gastroenterology (ACG) 2016 Annual Scientific Meeting: Abstract 11. Presented October 17, 2016.
http://www.medscape.com/viewarticle/870470
LAS VEGAS — An edible bowel preparation successfully delivers polyethylene glycol (PEG) and electrolytes prior to colonoscopy, and was highly rated by patients in a randomized phase 2 trial.
"Many patients find the current options for colon preparation unpleasant, poorly tolerated, and difficult to complete. Advances are needed to develop a better-tolerated preparation," said investigator Douglas Rex, MD, from Indiana University Hospital in Indianapolis.
Bowel prep tops the list of reasons that approximately 40% of people eligible for colonoscopy screening do not undergo the procedure, he said here at the American College of Gastroenterology 2016 Annual Scientific Meeting.
The edible colonoscopy preparation meal kit from ColonaryConcepts is being developed by a different kind of multidisciplinary team: gastroenterologists, research chefs, and human-factors engineers. A pilot study presented at Digestive Disease Week 2015 revealed excellent or good cleansing in 10 of 10 patients.
In their dual-center, single-blind study, Dr Rex and his colleagues looked at six edible colon prep formulations — with different PEG and electrolyte doses and different meal kit items — to identify which formulation should proceed to phase 3 studies.
Fifty-one participants were randomly assigned to edible colon prep and 14 were assigned to a standard prep with either MoviPrep from Salix Pharmaceuticals or GoLYTELY from Braintree Laboratories.
Participants ranged in age from 40 to 75 years, 59% were women, and 94% were white.
Endoscopic Visibility
The primary outcome — an endoscopic visibility rating of good to excellent on the Aronchick Scale — was achieved by 93% of patients who received the top-rated edible prep formulation.
Secondary assessments included segment-by-segment visibility, safety, tolerability, and patient satisfaction. Physicians rated 89% of the segments as good or excellent on the Ottawa Bowel Preparation Scale.
All participants had undergone a previous colonoscopy so they could compare the experiences.
More patients in the edible-prep group than in the standard-prep group reported being satisfied or extremely satisfied with the process (64% vs 33%). However, a few participants preferred their previous preparation or saw no difference, Dr Rex reported.
The top-rated edible formulation, determined after a series of comparisons, consisted of three food bars (lemon, white chocolate, and coconut) and two shakes (vanilla and strawberry–banana), which delivered 332 grams of PEG 3350, and three drinks (one orange and two mixed berry), which delivered electrolytes.
Some of the edible formulations assessed contained items like soup and chicken with rice, but they were excluded from the analysis.
Food Bars, Shakes, and Drinks
All of the edible components contain USP national formulary ingredients, so the prep will be marketed as a drug kit. Patients will be instructed to consume five individual color-coded meals: a noon lunch, 3 pm snack, 6 pm dinner, 8 pm snack, and 7 am breakfast. The one shake taken on the morning of colonoscopy makes this a split preparation.
"The edible colonoscopy preparation appears to be at least as effective and safe as currently available colonoscopy preparations," Dr Rex said.
There were no significant laboratory or vital sign abnormalities, no serious adverse events, and no unexpected serious adverse reactions with the edible prep, he reported. Typical adverse events with standard bowel prep include nausea, vomiting, burning, and soreness.
We all know that the worst part of the procedure is the bowel prep.
"Edible prep could represent a major advance in our ability to screen patients with colonoscopy, because we all know that the worst part of the procedure is the bowel prep," said session comoderator Mark Pochapin, MD, from the NYU Langone Medical Center in New York City.
"The preliminary data are very exciting, and a prep that is more palatable may improve the overall experience of a colonoscopy," he told Medscape Medical News.
"We all know the potential life-saving aspects of colonoscopy, and a better-tolerated prep could help us increase the number of patients screened," he added.
"This is a low-volume prep," Dr Rex responded when session comoderator Elena Stoffel, MD, from the University of Michigan in Ann Arbor, asked whether there are populations the edible prep is not suitable for. "There will always be patients who require a more aggressive preparation," he said.
Dr Stoffel also asked about the use of edible prep for patients with diabetes.
"That is unclear at this time" because diabetic patients were excluded from the study, Dr Rex explained. "We will need more information to know how it will do in obese patients, diabetics, and patients with some predictors of failed prep."
A phase 3 study is planned for the first quarter of 2017.
Dr Rex is a consultant for ColonaryConcepts. Dr Pochapin and Dr Stoffel have disclosed no relevant financial relationships.
American College of Gastroenterology (ACG) 2016 Annual Scientific Meeting: Abstract 11. Presented October 17, 2016.
