TARLAKENYO (Feb. 14 2023) — Doctors may now prescribe a new remedy for chronic constipation in the shape of a vibrating pill.
Vibrant, a first-of-its-kind therapy developed by the medical equipment business Vibrant Gastro, received FDA approval in August 2022. According to a corporate press release, it became available for doctors to prescribe this week.
Chronic constipation is thought to afflict approximately 16% of Americans. Unlike other digestive disorders such as inflammatory bowel disease (IBD), chronic idiopathic constipation—also known as functional constipation—is characterized by strenuous, infrequent, or incomplete bowel movements with no underlying physiological reasons or disease evidence.
Chronic constipation is often treated with dietary changes, such as consuming more fiber or taking osmotic or stimulant laxatives. Vibrant, on the other hand, is a drug-free capsule that gives mechanical stimulation to the large intestine from within.
“The pills trigger specialized nerve cells in the gut called mechanosensory cells,” Vibrant Gastro’s chief marketing officer, Ben Feldman, told Health. “These aid in the activation of peristalsis, the undulating muscle contractions that aid in the passage of food through the gut.”
The concept of a vibrating tablet to cure constipation may appear futuristic, but the FDA-approved medication has been demonstrated to bring significant relief to those suffering from chronic constipation.
Vibrant improves intestinal motility by providing mechanical assistance to the body’s biological clock. The pill’s vibrations may help “wake up” the body’s digestive system, according to Rudolph Bedford, MD, a gastroenterologist at Providence Saint John’s Health Center who is not connected with the treatment.
The pills are to be taken orally and before going to bed five evenings per week (the suggested cadence is: three days on, one day off, two days on, one day off). The capsules must be triggered before usage with the included pod. It should only take a few seconds to activate.
When activated, a capsule should be consumed promptly with a glass of water. When the capsule is taken, it activates and remains in the body for two hours; it then turns off for six hours before restarting for another two hours.
“The mechanical stimulation’s pre-programmed timing is thought to increase colonic motility by utilizing the body’s biological clock,” Feldman explained.
When in activation mode, the capsule vibrates almost continually in the body. “There are small sensations for three seconds on, three seconds off,” Cathy Collis, Vibrant Gastro’s chief commercial officer, said in a company news release.
The capsule can be tracked while it is in your body, and once it has passed through the gastrointestinal tract, it is eliminated through a bowel movement.
Vibrant has to be shown in clinical trials to be safe and effective to be approved by the FDA.
In a limited phase 3 study of 312 individuals with chronic idiopathic constipation, researchers discovered that Vibrant resulted in one more bowel movement in approximately 40% of patients who took the vibrating pill, compared to 23% in the control arm. On Vibrant, about 23% of patients had two more bowel motions per week, compared to just about 12% in the control group. 3
Although Vibrant cannot be directly compared to other medications on the market because it was not examined in a randomized controlled trial, the capsules were slightly better tolerated than the placebo used in the clinical trial. People who took Vibrant reported less overall abdominal pain, distention, and gastrointestinal issues than those who took the placebo tablet. Despite being uncommon, Vibrant had a slightly greater incidence of nausea, vomiting, and diarrhea than placebo tablets.
And while some patients were able to feel the Vibrant vibrations, they were not distracting enough to force people to stop using it.
“A minority of people may experience it,” noted Eamonn Quigley, MD, chief of gastroenterology at Houston Methodist Hospital, in a corporate news release. “None of them thought it was awkward. And none of them stopped taking medication as a result.”
Because Vibrant is a drug-free treatment option, the FDA classifies it as a Class 2 medical device, indicating that the capsules pose a moderate risk and necessitate stringent measures to assure its safety. (Contact lenses and pregnancy test kits are examples of Class 2 medical equipment.)
Feldman added that the capsules comprise a medical-grade polymer used for pill cameras that gastroenterologists employ in certain situations.
“To obtain FDA approval, Vibrant had to demonstrate that the tablets had no harmful components and that they could resist, for example, the force of a bite if someone accidentally bit them,” Feldman explained. The company also had to demonstrate that the capsules would not produce side effects such as infections or skin irritation and that they would not interfere with electronic gadgets, become stuck, or be completely ineffective.