NEWTON, MA, May 8, 2023 – Vibrant Gastro, a medical technology company that developed an FDA-cleared drug-free treatment for chronic idiopathic constipation (CIC) in adults, today presented an abstract at the 2023 Digestive Disease Week Conference in Chicago. Vibrant® uses gentle vibrations to mechanically stimulate the colon causing the colon to contract and effectively propel its contents. Vibrant’s timed stimulation is optimized to deliver vibrations which helps the colon contract mechanically in sync with the body’s natural circadian rhythm.
Chronic constipation is a common condition, impacting up to 20% of Americans. A large proportion of patients try more than one over-the-counter medication. When these fail, prescription medications are used, but these can cause unpleasant side effects, such as diarrhea.
The abstract, titled, “The Colonic Biological Clock and Predictability of Time of Bowel Movements During Treatment with a Vibrating Capsule (Vibrant®) in Patients with Severe Chronic Idiopathic Constipation,” summarizes a post-hoc analysis of the phase 3, multicenter, randomized, double-blind, placebo-controlled 8-week trial of the vibrating capsule in a subgroup of severe CIC patients (n=175, 56% of total study population).
Key takeaways from the study results include:
- Patients who experience severe chronic constipation tend to move their bowels later in the day, suggesting they have an altered colonic circadian rhythm.
- Patients with severe CIC experienced a significantly greater number of complete spontaneous bowel movements (CSBM) with the Vibrant capsule compared to the placebo.
- Complete spontaneous bowel movements (CSBM) predominantly occurred in the latter half of the day in both groups, with the cumulative average number of CSBMs for the 8-week treatment period being significantly higher for the vibrating capsule vs. the placebo between 6:00 p.m. and 10:00 p.m., showing predictable time of bowel movements.
- Optimal treatment of patients with CIC requires awareness of this abnormal colonic circadian rhythm in these patients.
“Until now, patients who experienced chronic constipation had to accept their status quo to treat with medications that in some cases led to unpredictable bowel movements and treatment-related side effects, such as diarrhea. We know that these treatments can negatively impact quality of life and mental wellbeing,” said Anthony Lembo, M.D., Cleveland Clinic, one of the primary investigators of the study. “I am very encouraged by the Vibrant study results. I’m excited that there is now a drug-free option that has the potential to help patients be more in control of the timing of symptom management, so they can work and live their lives without worrying about treatment onset.
“The Vibrant capsule provides patients with a drug-free alternative that can relieve their chronic idiopathic constipation symptoms. For prescribers the vibrating capsule represents a novel, effective and safe alternative for treating CIC “ said Darren M. Brenner, M.D., Northwestern Medicine.
Vibrant received market clearance from the U.S. Food and Drug Administration in August 2022, and is currently available by prescription.
Vibrant Gastro is the pioneer of the Synchronized Activation Method™, a first-in-class drug-free technology system using gentle vibrations to stimulate the colon mechanically. The pre-programmed timing of the mechanical stimulation improves natural colonic motility by leveraging the colon’s biological clock. The technology system allows future opportunities for developing data-driven personalized treatments, and additional indications leveraging the gut-brain connection via the Enteric Nervous System (ENS) pathway.
Vibrant Gastro’s first indication is for treating adults with chronic idiopathic constipation (CIC) who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.
To learn more about Vibrant, visit www.vibrantgastro.com.
Important Safety Information
The Vibrant Capsule is magnetic resonance (MR) unsafe. The device has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. Undergoing an MRI while the Capsule is inside your body may result in injury, including serious damage to your intestinal tract or abdominal cavity. If you require an MRI, instruct your physician to verify that no Capsules are currently in your body via abdominal X-ray before undergoing an MRI examination.
After ingesting a Vibrant Capsule and until it has left the body, you should not be near any source of powerful electromagnetic fields such as one created near an MRI device. The Capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC (direct current) magnetic field. If you have reasonable doubt concerning the integrity of a Vibrant Capsule, it should not be used and should be discarded. If after ingesting a Vibrant Capsule you experience black, bloody or tarry stools; experience abnormal abdominal pain including: new abdominal pain, if you had abdominal pain prior to using the device, then any change in the way your abdominal pain usually feels, or constant abdominal pain; experience nausea or vomiting believe that it has been 2 weeks and the Capsule has not left your body contact a physician immediately and stop taking additional Capsules until instructed by your physician.
Under no circumstances should a Vibrant Capsule be swallowed without prior activation in the Pod. Vibrant Capsules must be stored in a safe place, out of the reach of children and/or infants. If a child has accidentally swallowed an unused Vibrant Capsule, the child should be brought immediately to a hospital. Use of the Vibrant System next to or stacked on top of other equipment should be avoided because it could stop the Vibrant System from working properly. If such use is necessary, the components of the Vibrant System and the other non-Vibrant equipment should be checked to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Vibrant Pod, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Users should inspect the Pod and Capsule blister pack for possible tampering. Signs of possible tampering include but are not limited to: For the Pod – cracks or breaks in the Pod casing, scratches around the screw holes, and scratches/marks around the USB port that the user does not recognize. For the Capsule – damage to the blister cell, or the Capsule is not in a sealed blister cell.
If you suspect that someone tampered with the Pod, then the device should not be used. If you suspect someone tampered with the blister cell for a Capsule, then that Capsule should not be used.
Patients with pelvic floor dyssynergia (condition where the muscles in the pelvic floor no longer work in unison) may have impaired muscular ability to evacuate stool; therefore, they should be monitored for any signs of adverse response and to ensure ability to pass the Capsule.
The Vibrant System has not been assessed in patients with chronic use of non-steroidal anti-inflammatory drugs (NSAIDs). Chronic use means taking full dose NSAIDs more than three times a week for at least six months. The Capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC (direct current) magnetic field.