- A new drug-free option for constipation relief, Vibrant, receives FDA approval and is now available for prescription by physicians.
- Single-use vibrating capsule is meant to complement dietary, prescription, and over- the-counter options already available to patients.
- Experts see the product, at this stage, as part of a wider suite of options to discuss with patients.
Vibrant Gastro, a medical technology company based in Newton, Massachusetts, has come to market with a vibrating capsule meant to stimulate the colon and reduce chronic idiopathic constipation (CIC).
That product, named Vibrant, received marketing approval from the Food and Drug Administration (FDA) in August 2022, but physicians have only just started being able to prescribe it.
Dr. Pratima Dibba, a board-certified gastroenterologist at Medical Offices of Manhattan, says that tools like Vibrant are part of a wide range of treatment options for those with constipation of this type.
“Typically, patients are counseled to attempt lifestyle changes such as increasing dietary fiber, hydration and physical activity. If patients do not respond to lifestyle modifications, they are advised to trial over-the-counter medications and if refractory to those, patients are then offered prescription medications.”
Dibba says that those over-the-counter options are often things like fiber supplements, MiraLAX, senna, and Dulcolax.
How does It work
According to the company, Vibrant works because it “uses gentle vibrations to stimulate the colon mechanically.” They call this trademarked technology “the Synchronized Activation Method”. The product went through multiple clinical trials before its approval by the FDA. It should be noted that those clinical trials were fairly small, with the phase three trial including 349 participants and that its focus was not on comparing it to pharmacological alternatives.
One of the key selling points of the product is that it has the potential to reduce side effects because of its lack of pharmaceutical ingredients.
Yelena Wheeler (MPH, RDN), a registered dietician nutritionist with MIDSS and a clinical nutrition manager with Glendale Adventist Medical Center in Glendale, California, says that what piqued her interest in the product was the possibility for it to benefit patients who may have difficulty with treatments that include medical ingredients.
“Let’s say, they have an obstruction, or they have gastroparesis due to diabetes, or they just had surgery and they have an ileus [where the gut does not work properly] and their gut’s not functioning all that well…because those patients also tend to be on various medications,” Wheeler said. “Having something that is not going to interact with a lot of medications they’re already on. I found that pretty intriguing.”
The researchers working on the trials measured factors like quality of life, stool consistency, bloating, and straining score to determine the capsules’ effects for up to eight weeks. The largest takeaway was that a significant number of study participants had an increase in spontaneous bowel movements.
According to a 2021 article published in Clinical and Experimental Gastroenterology, somewhere between 10 and 17% of the world’s population is impacted by CIC. That research pointed to a wide-ranging set of treatments that are currently in use, including laxatives, magnesium, and transanal irrigation.
Dibba says that patients need to have an in-depth conversation with their physician before using a product like Vibrant.
“A patient should ensure that they have disclosed interventions they have already tried for constipation, their history of bowel surgeries, and any possible bowel conditions with their physician.”
Dibba adds that there are health issues patients should be mindful of when taking this pill.
“Although this particular scenario has not been reported in existing studies, one potential concern is that the use of Vibrant could result in pill retention, which is specifically an issue for patients with a history of abdominal surgery, bowel obstruction and/or inflammatory bowel conditions.”
Food, hydration, and movement
Wheeler says that, from a nutritional and lifestyle point of view, an increased amount of fiber and water can help turn your intestines into what she calls “a slip and slide.” She suggests a wide variety of food options to help decrease constipation risk.
These include “Green leafy vegetables, whole grains, that would be a good one, so brown rice instead of white rice, whole grain bread instead of white bread,” Wheeler said. Additionally, “eating the skins of the potato, legumes are also great sources of fiber. Eating the fruit instead of the fruit juice, dried fruit, [are] also a great source of fiber.”
Wheeler says that one question she has is whether more support could be given to dietitians in hospital settings and what role cost may play in Vibrant’s use. For her, constipation risk comes down to three areas: food, hydration, and movement.
“Even one of those pillars aren’t there as part of your daily lifestyle and intake, then you’re definitely in for higher risk for constipation.”
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