Drug-free chronic constipation relief may come from new vibrating pill

People struggling with chronic constipation have a new drug-free option to help get things working again.

It’s a unique capsule the size of a regular pill – but instead of releasing the medication upon swallowing, it vibrates to stimulate the colon.

The capsules, called Vibrant, were released by the Food and Drug Administration (FDA), an agency similar to Anvisa, in the United States in August, but only became available for medical prescription this week.

Doctors consider a person constipated when they have fewer than three bowel movements in a week. Between 10% and 20% of Americans live with persistent constipation for no apparent reason, according to a recent survey. They tend to have hard, dry stools that can cause pain and bloating.

The idea behind the treatment is that a single vibrant pill is taken at bedtime each day. It then travels the same path as food, passing through the stomach and small intestine, finally reaching the large intestine about 14 hours later. So she has her destiny.

The pills stimulate specialized nerve cells in the gut called mechanosensory cells. This helps trigger peristalsis, the rippling muscle contractions that help squeeze food through your intestines.

“There are little vibrations for three seconds on, three seconds off,” said Cathy Collis, commercial director at Vibrant Gastro, which is based in Israel but has offices in the United States.

Before use, each tablet is activated in a small capsule that binds it. Once swallowed, it’s active for about two hours, quiet for about six hours, and then active again for another two hours.

Finally, after doing their job, the person’s body evacuates and they are eliminated.

Capsules are not a cure. They are designed to be taken daily, just as you would with other maintenance treatments.

According to the company, the capsules are made from a medical material also used for the pill cameras that gastroenterologists have used for the past 15 years.

To gain FDA approval, 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 if someone accidentally bit into them.

The company also had to show that the capsules did not pose certain risks, such as causing infections, irritating tissues, interfering with other electronic devices, jamming or not working.

Like contact lenses and syringes, the FDA considers the product to be a Class 2 medical device, which means that they present an intermediate risk of causing harm to the user.

Once the pills reach the sewer, they are separated and taken to a landfill as a non-compostable material.

Less side effects

In a small clinical trial, 349 people with chronic constipation were divided into two groups: 200 who took the vibrating capsules every day for eight weeks and 149 who swallowed a similar pill that didn’t vibrate.

People who took the Vibrant pills reported being able to go to the bathroom more often and empty their bowels more completely compared to those who didn’t take the active pills.

About 40% of the group taking the Vibrant pills reported having at least one additional bowel movement per week, compared with about 23% of the placebo group. They also reported softer stools and less bloating.

The percentage of patients who reported two or more additional bowel movements each week was 23% in the group taking the Vibrant Pills and about 12% in the group taking the placebo.

Most people said they couldn’t feel the pills working, but some did.

“A minority can feel it,” said Eamonn Quigley, chief of gastroenterology at Houston Methodist Hospital. Quigley helped test the capsules, but has no financial stake in the company. “None of them felt they were being uncomfortable. And none of them stopped taking them because of that.”

He says he can’t directly compare the effectiveness of Vibrant capsules to other types of medicine because they weren’t tested head-to-head in the study. But he says the degree of relief with Vibrant capsules appears to be similar to how prescription constipation medications performed in their clinical trials.

People who took Vibrant capsules did not report serious adverse events such as bowel obstructions. More digestive side effects were reported in the placebo group than in the Vibrant group: 9.4% vs. 6.5%, respectively. Two people who took the Vibrant capsules reported diarrhea, but it was not common.

“One of the important side effects it doesn’t have is diarrhea, as many prescription drugs can cause diarrhea,” Quigley noted.

This is because most prescription medications for constipation work in the small intestine, where they release more fluid and secretions when digesting food.

Satish Rao, distinguished chair of gastroenterology at the Augusta University School of Medicine, says there’s no question that prescription drugs for constipation work, but they target a different area than the vibrating pill.

“If you think about it from a mechanistic perspective, they’re working a little bit further away from where the problem is, but they’re helping with the problem,” said Rao, who also helped test the capsules.

On the other hand, Vibrant capsules work in the colon, which is the source of the problem, he says.

Stimulating the gut without medication

Vibrating Capsules are programmed to work in a specific way and are FDA-cleared only to treat chronic constipation in adults who have not received help or cannot tolerate the side effects of over-the-counter or prescription medications.

People who have trouble swallowing or who have paralysis of the stomach, called gastroparesis, shouldn’t take Vibrant pills, Cathy said. They are also not a good idea for people with a history of bowel obstructions.

But Rao believes that with more study and tweaking, experts can reprogram the pills to work at an earlier stage, perhaps in the stomach, potentially helping people with gastroparesis.

He thinks it might also be possible to customize the capsule’s programming to better meet the needs of individual patients.

Currently, Vibrant is not covered by insurance, says Cathy. For those with health insurance, the company is offering a coupon to limit out-of-pocket costs to $69 per month. They are not a cure; people need to take them consistently to see relief.

“We are now working with insurers to get coverage into commercial plans,” she said. “But until we get that coverage, our goal and commitment is to make sure it’s affordable for patients.”