Gastroenterology & GI Surgery

Latest Vibrant Results Evaluate Effectiveness of Different Activation Modes

Sep. 29, 2023 - Eden McCleskey

Vibrating capsules that stimulate the bowels non-pharmacologically are significantly more effective than a placebo whether they're activated in the afternoon or morning, according to a new Houston Methodist-led study.

The phase III clinical trial evaluated the efficacy of the two activation modes of VibrantĀ®, a new FDA-approved treatment for chronic idiopathic constipation (CIC).

"Although our study showed that both activation modes were more effective than placebo, it remains to be seen if personalizing the time of vibrations will produce a preferential response in patients with CIC," said Dr. Eamonn Quigley, chief of Gastroenterology at Houston Methodist and the study's primary investigator. "Further studies are warranted."

Dr. Quigley will present more detailed results from the trial at the American College of Gastroenterology Annual Scientific Meeting in Vancouver on October 24, 2023.

Vibrant, which represents a therapeutic breakthrough for the millions of people worldwide who suffer from CIC, was found to be significantly more effective than a placebo at increasing complete spontaneous bowel movements (CSBM) at both Mode 1 (bowel stimulation during the p.m.) and Mode 2 (bowel stimulation during the a.m.).

For patients seeking relief of one additional CSBM per week over their baseline, Mode 1 demonstrated an impressive 39.02% response rate, followed by Mode 2 at 31.43%. In contrast, the placebo group reported a 20% response rate.

For those seeking two additional CSBMs per week over their baseline, Mode 1 and Mode 2 demonstrated nearly equal effectiveness, with response rates of 26.83% and 25.71%, respectively, well above the 10% reporting similar results in the placebo group.

The trial, conducted over eight weeks and involving a diverse patient cohort with CIC, aimed to determine the most effective mode of activation for the Vibrant capsule developed by Yokneam, an Israel-based company that also produces capsule endoscopy technologies.

The study enrolled a total of 116 participants, divided into three arms: Mode 1 (41 subjects), Mode 2 (35 subjects) and a placebo group (40 subjects).

All participants took capsules at 10 P.M. as part of the trial protocol.

To learn more about the clinical trial that led to Vibrant's FDA approval, click here.

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