Colonoscopy prep food bars, smoothies have been developed
They are scheduled to enter phase 3 trials next year
When it comes to undergoing a colonoscopy, a screening test for colon cancer, many patients agree that the preparation is the worst part.
To clear the colon and rectum for doctors to examine them for early signs of cancer, patients must guzzle a gargantuan amount of a salty, repulsive-tasting drink and laxative. While there are many different brands of this drink available, most of them have the same “ick” factor.
Many patients avoid the procedure because the preparation process is so unpleasant, said Dr. Douglas Rex, a professor of medicine at Indiana University. However, 40% of all colon cancers might be prevented if people underwent regular colonoscopy screenings, according to the Harvard School of Public Health.
“Bowel preparation is the most commonly cited reason for not undergoing colonoscopy, and this is true even for patients who have never had a colonoscopy,” Rex said. “This means the word is out that bowel preparation is generally unpleasant, and efforts to improve the tolerability of colonoscopy bowel preparation are an important aspect of the drive to lower colorectal cancer incidence and mortality.”
Now, the Boston-based company ColonaryConcepts aims to answer many colonoscopy patients’ prayers by developing bowel-clearing food bars and drinks that taste more like fruit smoothies and chocolate – but more research is needed before these bars will be available to the public.
The bars come in three flavors, lemon cooler, coconut and white chocolate. Smoothies come in two flavors, strawberry-banana and vanilla shake, and the beverages also come in two flavors, mixed berry and orange.
The bars and drinks, which recently have been tested in a phase 2 trial, contain the same purgative active ingredient, called polyethylene glycol (PEG) 3350, that is often used in colonoscopy prep products.
“I’m really proud that we’ve invented something different that makes the experience so much easier,” said Dr. Corey Siegel, a gastroenterologist at the Dartmouth-Hitchcock Medical Center and the Geisel School of Medicine at Dartmouth, who is a co-founder of ColonaryConcepts.
“Colon cancer is very treatable when caught early, and the best way to catch it early or prevent it entirely is colonoscopy,” he said. “We really have a public health problem on hand with people not wanting to do it because of the preparation.”
Rex will present the results from the phase 2 trial at this year’s American College of Gastroenterology annual scientific meeting in Las Vegas on Monday. He was the principal investigator for the trial.
Testing for market
Six formulations of the new food bars and drinks were tested in the phase 2 trial among 51 patients, in preparation for their colonoscopies. Those test results were then compared with two other pre-colonoscopy drinks, called Moviprep and Nulytely, already approved by the Food and Drug Administration and given to 14 patients.
For the top three most effective bars and drinks by ColonaryConcepts, the doctors conducting the colonoscopies rated the bowel cleansing of about 90% of the patients using the experimental prep as “excellent” or “good” in terms of effectiveness. For Moviprep and Nulytely, fewer patients – about 85% – were rated “excellent” or “good” in the cleaning achieved.
The proportion of patients who reported that they were satisfied with the bars and drinks was about 64%, whereas only about 33% reported that they were satisfied with the Moviprep and Nulytely products, according to the trial results.
Overall, test scores to rate “cleansing” for the new items were numerically better than the comparator products, Rex said, “and resulted in improved patient satisfaction and willingness to repeat the preparation.”
“The results showed that a formulation of three food bars and two shakes containing PEG plus three glasses of electrolyte drink provided the best cleansing,” he said.
So, instead of fasting for 24 hours before a colonoscopy and having to drink a salty, distasteful liquid, patients could start their pre-colonoscopy process with eating the bars and a beverage for lunch and dinner, and then a smoothie for the morning.
This new colonoscopy prep is scheduled to begin phase 3 trials early next year. If the trial results appear promising, then the product could enter the market as soon as in 2018.
The bars are also being tested in a separate study to determine whether they could be used to treat constipation, Siegel said.
’It’s better to not put it off’
This isn’t the first time that alternative options for colonoscopy preparation have been developed.
A study presented at the Digestive Disease Week conference in May found that certain solid foods – from eggs to cheese to chicken breast – consumed before a colonoscopy resulted in patients feeling more comfortable during the 24-hour preparation process than when they were instructed to only consume liquids.
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Some patients opt to trade in a traditional colonoscopy for a laxative-free virtual colonoscopy, in which x-rays and a computer are used to create scanned images of a patient’s colon for doctors to examine. However, with this option, doctors wouldn’t be able to immediately remove a colon polyp, or small clump cells that could develop into cancer, if detected.
For now, Rex recommended that patients should speak with their doctors about ways to improve the tolerability and cleansing effect of their preparation process before a colonoscopy.
“If your doctor has advised a colonoscopy, it’s better to not put it off,” he said.