Functional Bowel Disease

73 - Mechanism of Action of Vibrant Capsule for the Treatment of Chronic Idiopathic Constipation: Pooled Results of 2 Different Studies

Wednesday, October 10
9:50 AM - 10:00 AM
Location: Terrace Ballroom 2-3 (level 400)

Category: Functional Bowel Disease
Satish S.C. Rao, MD, PhD1, Anthony Lembo, MD2, William D. Chey, MD, FACG3, Keith Friedenberg, MD4, Jorge Loredo, DO5, Kathleen Kelly, MD6, Lydie Hazan, MD7, Viv Huilgol, MD8, Daniel Lindenberg, MD9, Jeanette Straga, DO10, Joseph Lillo, MD11, Hai Nguyen, MD12, Patrick Dennis, MD13, Chester Fisher, MD14, Paula Lane, MD15, Dena Peterson, MD16, Duane Anderson, MD17, Hessam Aazami, MD18, Barry Heller, MD19, Sean Su, MD17, Amit Paliwal, MD20, Eamonn M.M. Quigley, MD, MACG21, Bradley Block, MD22
1Augusta University Medical Center, Augusta, GA; 2Harvard Medical School, Boston, MA; 3University of Michigan, Ann Arbor, MI; 4Great Lakes Gastroenterology Research, Mentor, OH; 5Floridian Research Institute, Miami, FL; 6Biofortis Clinical Research, Addison, IL; 7ACTCA, Los Angeles, CA; 8NOLA Research Works, New Orleans, LA; 9Clinical Research Center of Florida, Pompano Beach, FL; 10ICT Las Vegas, Las Vegas, NV; 11Elite Clinical Studies, Phoenix, AZ; 12DelRicht Research - Gretna, Gretna, LA; 13DelRicht Research - NOLA, New Orleans, LA; 14Health Research of Hampton Roads, Newport News, VA; 15Albuquerque Neuroscience, Albuquerque, NM; 16Noble Clinical Research, Tucson, AZ; 17Excel Clinical Research, Las Vegas, NV; 18Hope Clinical Research, Canoga Park, CA; 19Long Beach Clinical Research, Long Beach, CA; 20Empire Clinical Research, Upland, CA; 21Houston Methodist Gastroenterology Associates, Houston, TX; 22Oviedo Medical Research, Oviedo, FL

Introduction: Chronic constipation is a multifactorial gastrointestinal (GI) disorder. Although several treatments are available, many patients remain dissatisfied and desire new therapies. The orally administered intraluminal vibrating capsule (VC) (Vibrant Ltd., Yokneam, Israel) is the first chemical-free treatment that improves constipation by mechanically inducing vibrations. Our aim was to determine the effects of VC on complete spontaneous bowel movements (CSBMs) in patients with chronic idiopathic constipation (CIC), using 2 paradigms of VC activation.

Methods: Patients with CIC who fulfilled Rome III criteria were enrolled in 2 double-blind, sham-controlled studies. Subjects ingested 5 capsules per week for 8 weeks. Patients in study 1 (n=182) received a single vibration session, and in study 2 (n=63) multiple (3) vibration sessions/day using similar frequency in both studies. Bowel symptoms were recorded on daily stool diary.

Results: Data on CSBM frequency from the 2 studies were pooled for this analysis. A significant correlation was found with single vibration (study 1) between the time of pre-defined vibration and the frequency of occurrence of CSBM over 24 hours (figure 1). The number and percentage of CSBMs were higher in the active arm (p<0.0018) compared to sham arm (figure 1), and coincided with the timing of vibration as preprogrammed for the capsule (8-12 hours from administration 1st peak). In addition although there is sham response (natural circadian rhythm), it drops dramatically the next morning, (hours 34-36), while VC active arm shows greater activity during that time (24 hours from last vibration) (figure 2). In study 2, because of multiple vibration sessions, 2 peaks were seen: 1st peak around 8-12 hours followed by a 2nd peak around evening time (figure 3). Significant clinical correlation was found with multiple vibration sessions and CSBM (p<0.0357).

Discussion: VC significantly increases the number of CSBMs when compared to sham and this coincides with VC activation. This observation suggests that the mechanism of action of VC is to induce bowel movements through mechanical vibration of the colon, augmenting colonic biorhythm and peristalsis. This unique, non-pharmaceutical modality could be a novel approach for constipation.

Figure 1: Correlation between vibration time and frequency of CSBM - single vibration session
Figure 2: Vibration during 48 hours
Figure 3: Correlation between vibration time and frequency of CSBM - multi vibration sessions

Disclosures:
Satish Rao: Vibrant – Advisory Committee/Board Member, Grant/Research Support.
Anthony Lembo: Vibrant – Investigator.
William Chey: Vibrant – Investigator.
Keith Friedenberg indicated no relevant financial relationships.
Jorge Loredo: Vibrant – Investigator.
Kathleen Kelly: Vibrant – Principal Investigator.
Lydie Hazan: Vibrant – Principal Investigator.
Viv Huilgol: Vibrant – Principal Investigator.
Daniel Lindenberg: Vibrant – Investigator.
Jeanette Straga: Vibrant – Principal Investigator.
Joseph Lillo: Vibrant – Principal Investigator.
Hai Nguyen: Vibrant – Principal Investigator.
Patrick Dennis: Vibrant – Principal Investigator.
Chester Fisher: Vibrant – Principal Investigator.
Paula Lane: Vibrant – Principal Investigator.
Dena Peterson: Vibrant – Principal Investigator.
Duane Anderson: Vibrant – Principal Investigator.
Hessam Aazami: Vibrant – Investigator.
Barry Heller: Vibrant – Principal Investigator.
Sean Su: Vibrant – Principal Investigator.
Amit Paliwal: Vibrant – Amit R. Paliwal, MD.
Eamonn Quigley: Vibrant – Principal Investigator.
Bradley Block: Vibrant – Principal Investigator.

Satish S.C Rao

Professor of Medicine
Digestive Health Center, Medical College of Georgia
Augusta, GA, US

Dr. Satish Rao received his MD from Osmania Medical College, Hyderabad, India, his PhD from the University of Sheffield, U.K., and the Fellowship of the Royal College of Physicians (FRCP) in London, UK, in 1997. Having spent 20 years at Iowa where he was a Professor of Medicine and Director, Neurogastroenterology and GI Motility and Biofeedback Program, University of Iowa Carver College of Medicine, Iowa City, Dr. Rao recently moved to Medical College of Georgia, Georgia Regents University, in Augusta, where he is a Professor of Medicine, Division Chief, Gastroenterology/Hepatology and Founding Director, Digestive Health Center. Dr. Rao is one of a rare breed of academicians who has excelled as an outstanding researcher, distinguished educator and as a Master Clinician. Dr. Rao's research interests focus on the pathophysiology and treatment of IBS, food intolerance (particularly fructose intolerance), constipation and fecal incontinence, and visceral pain, particularly esophageal chest pain. He is the only physician to date who has received all 3 meritorious honors from the AGA: the AGA Distinguished Clinician Award, AGA Masters Award for Outstanding Clinical Research, and the AGA Distinguished Educator Award. In 2005 he received an ACG Auxiliary Research Award, and in 2007 the ACG Novartis Motility research award for the best research paper. Dr. Rao has edited several books, Disorders of the Anorectum (2001), Anorectal and Pelvic Floor disorders (2008) for Gastroenterology Clinics of North America, Gastrointestinal Motility Tests and Problem-Oriented Approach and GI Motility Testing - a Laboratory and Office Handbook (2010, Co-editor). He has published over 300 articles. He is an astute clinician with an international reputation and has been selected as one of the "Best Doctors in America" and America's Top Doctors for over 15 years. He is Past President of the American Neurogastroenterology and Motility Society.

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