Vibrant (smart capsule for constipation)

Start of sales. Price

In early February 2023, sales of a non-drug constipation drug, a smart capsule called Vibrant, began. She has a companion smartphone app through which to watch the treatment process and send reminders to take the capsule. The novelty is available by subscription at a price of $2-3 per day.

Vibrant is drug-free and works by vibration that stimulates nerve cells in the gastrointestinal tract (GI). Stimulation helps trigger peristalsis in the human body. A prescription-only medical device, it is approved by the Food and Drug Administration (FDA) as a second class medical device. The agency approved pills for the treatment of chronic constipation in adults who were not helped by other therapy options or with intolerance to over-the-counter or prescription drugs.

Vibrant capsule

For the normal performance of all functions of the gastrointestinal tract, normal intestinal peristalsis is required. This is the motor activity of different parts of the digestive system. Such contractions of smooth muscle contribute to the movement of processed food to the exit. The frequency of peristaltic movements in different parts of the gastrointestinal tract varies. Under the influence of various factors, peristalsis can be disturbed. These failures lead to stool problems, accelerated reproduction of disease-causing bacteria, slower absorption of nutrients and other problems. As of February 2023, according to the FDA, 10% to 20% of Americans have chronic constipation, which is diagnosed as having fewer than three bowel empties in a week.

The Vibrant smart capsule passes through the stomach and small intestine in the same way as food. The agent must be taken every day, the capsule is intended only for daily supportive treatment. 14 hours after administration, the pill reaches the large intestine and begins to work, through stimulation of nerve cells in the intestine and causing muscle contractions.^[1]

In the clinical trial, 349 people with chronic constipation were divided into two groups: 200 took vibrating capsules every day for eight weeks, and 149 people swallowed a similar pill that did not vibrate. About 23% of participants in the placebo group and 40% of people who received the capsules reported experiencing at least one additional bowel emptying per week. One in four participants taking Vibrant and about 12% in the placebo group reported two or more additional defecations each week. The capsule caused no side effects, although some participants felt a slight vibration and two experienced diarrhea.

2022: Product Announcement

In early September 2022, Vibrant Gastro introduced a vibrating capsule that treats chronic constipation. This comes after a pivotal clinical trial established a link between oral medication-free capsules and an increase in the number of complete spontaneous bowel emptying. The device mechanically stimulates the colon to treat adults with chronic constipation.

Chronic constipation is a problem for millions of people despite the availability of over-the-counter and prescription drugs, and its prevalence in North America is estimated to range from 2% to 27%. Work to improve the results included the development of external vibration devices such as belts and platforms that provide mechanical stimulation.

Vibrant smart constipation capsule

The Vibrant device is a vibrating capsule, the device is designed to improve external devices by stimulating the intestinal walls through local contact and thereby increasing the movement of the stool. To test the hypothesis, the researchers included 312 patients with chronic constipation in 90 American clinics in the study.

The results of the study, whose data were presented in May 2022, showed that 39.26% of patients taking Vibrant had one or more complete spontaneous bowel emptying per week from baseline, compared with 22.15% of their controls. The proportion of participants who had two or more additional bowel emptying was also higher in the treatment group - 22.7% than in the control group - 11.41%.

None of the participants reported serious adverse events, diarrhea or treatment-related nausea, allowing Vibrant Gastro to obtain data that convinced Ministry of Health USA the device to be authorized. Users of the device will place each device in a capsule. Then the device is activated, and after, the patient swallows the capsule, washing it down with a glass of water, and uses a companion app to monitor treatment.^[2]

Notes