Small electronic capsules that help with infrequent bowel movements are now available by prescription.
A new electronic pill is about to shake things up when it comes to chronic constipation relief. Flour Vibro Sifter
As of this week, doctors can prescribe Vibrant, a first-of-its-kind alternative to conventional laxatives. The patient swallows the capsule, and it makes its way to the colon, where it vibrates to stimulate natural movement in the gut.
About the size of a typical vitamin pill, the capsule was granted marketing authorization by the U.S. Food and Drug Administration (FDA) in August 2022. Vibrant is approved to treat chronic idiopathic constipation (constipation without a known cause) in those who have not had relief from other laxative therapies for at least a month.
Symptoms of chronic constipation include having fewer than three bowel movements per week, straining, hard stools, incomplete evacuation, and inability to pass stool, according to the UCLA Center for Neurology of Stress and Resilience. Up to 63 million people in North America meet the diagnostic criteria for chronic constipation.
“Vibrant should be viewed as another tool that is available to help patients, but it is not a cure for constipation,” says Linda Nguyen, MD, a gastroenterologist with Stanford Health Care in Palo Alto, California, who is not affiliated with the company that makes Vibrant. “Dietary, lifestyle, and other factors that can impact constipation should always be a part of every patient’s treatment plan.”
Vibrant contains a tiny microchip that is programmed to start vibrating when the pill reaches the large intestine, about 14 hours after ingestion. The capsule induces small vibrations inside the colon for two periods of two hours each, spaced six hours apart.
“The vibrations come on for a few seconds, and then off and then on,” says Satish Rao, MD, PhD, the director of the digestive health clinical research center at the Medical College of Georgia at Augusta University. “These vibrations locally induce muscle contractions, causing stools to move.”
After the pill passes through the colon, it leaves the body in the stool.
Dr. Rao headed up research that led to the FDA approval. Over eight weeks, he and colleagues followed 312 chronic constipation patients from more than 90 clinical centers across the United States who received either one Vibrant pill or a placebo (a sham pill) every day, five times a week.
Scientists discovered that about 39 percent of patients receiving Vibrant had one or more additional complete spontaneous bowel movements per week than when they started the treatment; 22 percent in the placebo group had similar increases.
The study noted that nearly 23 percent of patients who received Vibrant had two or more additional bowel movements per week, compared with about 11 percent in the placebo group.
Rao says the capsule’s mechanism of action is based on the scientific understanding of circadian rhythm, otherwise known as “the biological clock,” which plays an important role in the digestive process.
“The vibrations excite the brain through the nerve connections between the gut and brain, and this improves gut and brain interactions, and possibly restores intestinal circadian biorhythm that may be disturbed in many constipated patients,” he says.
The research demonstrated that Vibrant was safe and well-tolerated. Dr. Nguyen noted that the Vibrant capsule does not appear to cause diarrhea as a side effect, which is one of the most common issues with laxatives and other constipation therapies currently on the market.
The product is made of a medical grade material that is safe and inert in the human body.
The pills passed successfully through all participants in the clinical trials, but for patients with certain conditions, there may be a risk of the pill getting stuck in the gastrointestinal tract.
“Pill retention [where the pill does not leave the body] could occur if patients have a history of bowel obstructions, bowel surgeries, and inflammation in the bowel,” says Margaret Eugenio, MD, a gastroenterologist with the University of Washington Medical Center in Seattle. “In these cases of pill retention, endoscopy [inserting a long, flexible tube down the throat and into the esophagus] or surgery may be used to retrieve the pill.”
At this point, researchers do not know how long-lasting the benefits are.
“The studies so far suggest that after stopping the treatment, patients tend to go back to where they were — not to normal but back to being constipated,” says Eamonn Quigley, MD, the chief of gastroenterology at Houston Methodist Hospital, and one of the authors of the Vibrant research.
The current out-of-pocket cost is $89 a month, according to Ben Feldman, the chief marketing officer for Vibrant. For patients who have commercial insurance, the company offers an additional discount that would bring the price to $69 per month. The company is working with both Medicare and commercial insurers to seek coverage.
Vibrant capsules must be prescribed by a physician. If the doctor advises taking Vibrant, the product is shipped directly to the patient.
Electronic pills are not new. For example, doctors already use vitamin-size endoscopy capsules with tiny cameras inside to take pictures of the digestive tract.
“It’s amazing how they can make this technology so minute,” says Dr. Quigley. “There is a long history with this miniaturized capsule technology doing a variety of things without any significant problems.”
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