A New Vibrating Pill May Help Ease Chronic Constipation

Doctors may now prescribe a new treatment—in the form of a vibrating pill—to treat chronic constipation.

Vibrant, a first-of-its-kind therapy made by medical equipment manufacturer Vibrant Gastro, was cleared by the U.S. Food and Drug Administration (FDA) in August 2022. This week, it became available for doctors to prescribe, according to a company news release.

Chronic constipation is thought to affect about 16% of people in the United States. Unlike with other digestive diseases, like inflammatory bowel disease (IBD), chronic idiopathic constipation—sometimes known as functional constipation—is characterized by difficult, infrequent, or incomplete bowel movements without any underlying physiological reasons or evidence of disease.

Treatment options for chronic constipation typically include dietary changes, like eating more fiber, or taking osmotic or stimulant laxatives. But Vibrant is different—the drug-free capsule instead provides mechanical stimulation to the large intestine from the inside.

“The pills stimulate specialized nerve cells in the gut called mechanosensory cells,” Ben Feldman, chief marketing officer of Vibrant Gastro, told Health. “These help trigger peristalsis, the undulating muscle contractions that help squeeze food through the gut.”

The premise of a vibrating pill to treat constipation might seem futuristic, but the FDA-cleared treatment has shown to provide significant relief to people who deal with chronic constipation.

Drug-Free Relief Through a Vibrating Pill

Vibrant works by enhancing colonic motility by adding some mechanical help to the body's biological clock. According to Rudolph Bedford, MD, a gastroenterologist at Providence Saint John’s Health Center, who is not affiliated with the treatment, the pill’s vibrations may help “wake up” the body’s digestive system.

The pills are meant to be taken by mouth and before sleep for five nights per week (the suggested cadence is: three days on, one day off, two days on, one day off). The capsules must be activated before use with a pod that comes with them. The activation should take a few seconds.

After a capsule is activated, it's meant to be immediately swallowed with a glass of water. Once swallowed, the capsule is activated and remains on in the body for two hours; it will turn off for six hours after that, and then start up again for another two hours.

“The pre-programmed timing of the mechanical stimulation is thought to improve colonic motility by leveraging the body’s biological clock,” Feldman said.

When it’s in activation mode, the capsule nearly continuously vibrates in the body. “There are little vibrations for three seconds on, three seconds off,” Cathy Collis, chief commercial officer for Vibrant Gastro, said in a company news release.

You can track the capsule while it’s in your body, and once it makes its way through the body’s gastrointestinal system, it gets expelled through a bowel movement.

Safety and Effectiveness

In order to be cleared by the FDA, Vibrant had to be shown to be both safe and effective in clinical trials.

In a small phase 3 study including 312 patients with chronic idiopathic constipation, researchers found that Vibrant led to one additional bowel movement in about 40% of patients who took the vibrating pill, compared to 23% of people who were in the control arm. Approximately 23% of people had two additional bowel movements per week on Vibrant, compared to just about 12% of people in the control arm.

Although Vibrant can’t be directly compared to other drugs on the market as they weren’t tested in a head-to-head study, the capsules did appear to be slightly better tolerated than the placebo used the clinical trial. Compared to people who took the placebo pill, people who took Vibrant reported less abdominal pain, distention, and gastrointestinal disorders overall. Though infrequent, Vibrant did have slightly higher rates of nausea, vomiting, and diarrhea than placebo pills.

And though some patients were able to feel the Vibrant’s vibrations, they weren’t disruptive enough to force people to discontinue treatment.

“A minority could feel it,” Eamonn Quigley, MD, chief of gastroenterology at Houston Methodist Hospital said in a company news release. “None of them felt it was being uncomfortable. And none of them stopped taking it because of that.”

Because Vibrant is a drug-free treatment option, it’s classified by the FDA as a Class 2 medical device, which means the capsules have a moderate risk and require special controls to ensure their safe use. (Other common Class 2 medical devices include contact lenses and pregnancy test kits.)

The capsules are made of a medical-grade material which is also used for pill cameras that gastroenterologists use under certain settings, Feldman explained.

“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 a bite in case someone accidentally bit them,” Feldman said. The company also had to prove that the capsules wouldn’t cause side effects like infections or body tissue irritation, and that they wouldn’t interfere with electronic devices, get stuck, or be entirely ineffective.

A Treatment, but Not a Cure

Vibrant received FDA clearance for use in adults with chronic constipation who don’t get proper relief from laxatives after a month of use.

But while the pill saw some success in treating constipation, the therapy is not a cure. “If you had chronic constipation before you started taking it, you may still be constipated after,” Dr. Bedford said. “But it’s not going to worsen the situation or make your colon lazy.”

It’s up to a patient and their healthcare provider to determine whether Vibrant is the right course of treatment, but there are some patients for whom the pill is contraindicated, including:

• People with a history of complicated or obstructive diverticular disease.
• People with a history of intestinal or colonic obstructed, or suspected intestinal obstruction.
• People with clinical evidence of current and significant gastroparesis.
• People with a history of significant gastrointestinal disorder (inflammatory bowel disease, gastrointestinal malignancy, untreated/active celiac disease, and/or anal fissures and fistulas).
• People with a history of Zenker’s diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis, or achalasia.
• People who are pregnant or lactating.

Though Vibrant is currently more costly than other over-the-counter options—at about $89 per month—the company is working to make it more affordable. “We are working right now with insurance companies to obtain coverage in commercial plans,” Feldman said. “But until we get that coverage, our goal and commitment is to make sure that this is accessible and affordable to patients.”

If you’re interested in trying Vibrant, you can talk to your gastroenterologist to see if you qualify. From there, you’ll need to connect with the specialty pharmacy Carepoint about getting the treatment.