▎WuXi AppTec Content Team Editor
A few days ago, Vibrant Gastro announced that the US Food and Drug Administration (FDA) approved the launch of Vibrant, an innovative oral capsule for the treatment of patients with chronic idiopathic constipation. These patients remained symptom-free after taking the recommended dose of laxatives for a month. This therapy does not contain any drugs, it works by mechanically stimulating the gut to regulate the body’s biological clock, restoring the natural bowel biorhythm. The FDA press release states that this is the first FDA-approved treatment for constipation of this type. It is worth mentioning that a vibration capsule therapy with a similar mode of action hascompleted a clinical trial in China and has been approved by the National Medical Products Administration of China.
Constipation plagues a huge group of patients. According to the “Expert Consensus Opinions on Chronic Constipation in China”, the prevalence of chronic constipation in Chinese adults is 4.0% to 10.0%, with more than 50 million adults Suffered from constipation. People with chronic constipation have fewer than 3 bowel movements per week and symptoms persist for weeks to months. The patient also showed symptoms such as fecal induration, a sense of incomplete defecation, and labored defecation.
Constipation can occur for a variety of reasons, including lack of exercise, poor diet, lack of water, and intestinal flora disturbances. Chronic idiopathic constipation refers to constipation of unknown cause. Current treatments include soluble fiber, laxatives, etc. However, many treatments are ineffective or have side effects.
Image source: 123RF
In recent years, scientists have focused on the role of the enteric nervous system in a variety of diseases, including gastrointestinal disorders. The gut is innervated by millions of neurons. This neural network is also known as the “second brain” of human beings. The gut-brain axis formed with the brain is not only associated with gastrointestinal diseases, but also with Mental illnesses such as depression are also linked.
Past studies have shown that constipation symptoms can occur when the biological clocks of the central nervous system and digestive system are out of sync. The Vibrant System, developed by Vibrant Gastro, is a drug-free, single-use capsule. It can be programmed to control its movement patterns in vitro. After swallowing this capsule, it can generate gentle vibrations when entering the colon, stimulate the enteric nervous system by “massaging” the intestines, and resynchronize the biological clock through the signaling of the gut-brain axis to restore natural bowel movements Biorhythms. Thereby improving intestinal peristalsis, relieving symptoms of constipation, and improving the quality of life of patients.
Screenshot source: Vibrant Gastro official website
FDA approval is based on the results of a pivotal clinical trial involving 312 patients with chronic idiopathic constipation. The results of the trial showed that 40.51% of the patients receiving this systemic treatment increased the number of spontaneous complete bowel movements (CSBM) at least once per week, compared with 22.92% in the control group. In addition, 23.42% of patients in the treatment group experienced an increase in the number of spontaneous complete bowel movements at least two times per week compared to 10.0% in the control group. Regarding safety, no serious adverse events were reported in the group of patients treated with this system.
A clinical trial of a vibrating capsule with a similar mode of action has also been completed in China. In May of this year, a research team from 7 tertiary hospitals in China published a paper in The Lancet’s eClinicalMedicine, describing the use of vibrating capsules to treat 107 patients with functional constipation in a randomized, double-blind, placebo-controlled study clinical trial results.
Trial results showed that after 6 weeks of treatment, the proportion of patients receiving vibrating capsules and the control group increased at least one spontaneous complete bowel movement per week compared to baseline, respectively
strong>64.2% and 35.8%.
In February of this year, the State Drug Administration of China has approved the application for registration of an innovative product called “Digestive Tract Vibrating Capsule System”.
ConvenienceAlthough there are many treatment options, secretaria faces the challenges of high prevalence, high recurrence rate, treatment side effects, and low patient satisfaction. It is expected that this novel therapy will provide patients with a new treatment option that is safe, effective, and drug-free.
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