A first-of-its-kind treatment for chronic constipation has patients swallow a capsule that vibrates to stimulate the intestines.
The capsule, called Vibrant, was cleared by the US Food and Drug Administration in August and this week became available for doctors.
In the intestines, the vibrations are intended to stimulate specialized nerve cells called mechanosensory cells, which in turn trigger undulating muscle contractions that help squeeze food through the gut.
“There are little vibrations for three seconds on, three seconds off,” said Cathy Collis, chief commercial officer for Vibrant Gastro, which is based in Israel but has offices in the United States.
The pills are about the size of an oblong multivitamin. Before use, each pill is activated in a little pod that turns it on. After it’s swallowed, it is active for about two hours, goes quiet for around six hours and then activates again for another two hours.
After it has done its job, it’s pooped out and flushed away.
The capsule is not a cure. It is designed to be taken daily, around bedtime.
Vibrant is not currently covered by insurance, said Collis. For those who have health insurance, the company is offering a coupon to cap out-of-pocket costs at $69 per month.
According to the company, the capsules are made of a medical-grade material. To get FDA clearance, Vibrant had to demonstrate that there were no toxic materials in the pills and that they could withstand, for example, the force of an accidental bite.
The company also had to show that the capsules didn’t cause infections, irritate tissues, interfere with other electronic devicesor tet stuck.
Like contact lenses and syringes, the FDA considers them to be class 2 medical devices, meaning they carry intermediate risk of harm to the user.
Once the pills make their way into sewage, they are sifted out as non-compostable material.
Doctors consider a person to be constipated when they’re having fewer than three bowel movements in a week.
In a small clinical trial, with about 498 subjects, about 40% of the group taking the Vibrant pills reported having at least one additional bowel movement a week, compared with 23% of the placebo group. Most people said they couldn’t feel the pills working, but some did.
“One of the important side effects that it does not have is diarrhea, as a lot of the prescription drugs can lead to diarrhea,” said Dr. Eamonn Quigley, chief of gastroenterology at Houston Methodist Hospital. Quigley helped test the capsules, but he doesn’t have any financial stake in the company.
The-CNN-Wire
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