An innovative treatment for chronic constipation has received FDA approval following positive results from a Houston Methodist-led clinical trial.

Vibrating capsules that stimulate the bowels non-pharmacologically, known as Vibrant, will be available in select states in early 2023 before gradually expanding nationally throughout the year.

In a trial led by Dr. Eamonn Quigley, director of the Underwood Center for Digestive Disorders and chief of Gastroenterology at Houston Methodist, patients who took the vibrating capsules had an immediate and significant increase in the number of complete, spontaneous bowel movements compared to a group who got a placebo. Those in the treatment group also had significant improvements in secondary outcome measures, including straining, stool consistency and quality of life.

"After nearly a decade of development, studies and trial and error, we are excited to see such conclusive evidence that the treatment is safe, well tolerated and effective at improving the bowel and abdominal symptoms that give patients with chronic constipation so much trouble," says Dr. Quigley.

Dr. Quigley, one of the trial investigators, says the results were not only statistically significant but clinically significantly as well. He notes that most of the trial participants were averaging only one or two bowel movements per week and that "doubling that number has a tremendous impact."

A new approach for chronic constipation is badly needed. Nearly half of patients who suffer from the condition report dissatisfaction with currently available drugs and therapies.

The new treatment involves ingesting a capsule with a tiny microchip programmed to begin vibrating after eight hours, roughly when it is expected to hit the colon. It is manufactured by an Israeli company, Vibrant, based on the same technology that is used in capsule endoscopies.

This is the first treatment of its kind to vibrate within the gastrointestinal tract. Devices that provide external mechanical stimulation via the abdomen showed promise in clinical trials but have had limited impact since becoming available in Europe.

The Phase III trial enrolled 349 patients, 200 of whom got the vibrating capsules and 149 of whom got a placebo. In those who got the vibrating capsules, the trial found "a rapid onset of significant increase" in complete, spontaneous bowel movements within one week and a peak by the third week. The trend persisted thereafter.

Effective pharmaceutical remedies do exist for chronic constipation, but their side effects may include cramping and diarrhea. Additionally, a large percent of patients with chronic idiopathic constipation are elderly and may have medication contraindications.

"Most people have experienced severe constipation at some point in their lives," Dr. Quigley says. "The associated abdominal bloating and discomfort and the distress caused by attempts to pass a hard stool can impact severely on an individual's quality of life. There is a significant need for alternative treatments that really work. With this research and a lot of stick-to-it-iveness, we are excited to have one on the horizon."