A D Nelson1, M Camilleri1, A Acosta1, A Boldingh1, I Busciglio1, D Burton1, M Ryks1, A R Zinsmeister2. 1. Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, MN, USA. 2. Division of Biomedical Statistics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.
Abstract
BACKGROUND: In an open-label study of 26 patients with IBS-C and chronic constipation, treatment with a vibrating (VIBRANT) capsule twice a week for 7.5 weeks resulted in 88.5% responders. Effects on colonic transit are unclear. We aimed to compare effects of VIBRANT and sham capsule treatment on colonic transit in patients with functional constipation. METHODS: Patients with functional constipation (Rome III criteria) were randomized to VIBRANT or sham capsule treatment for 8 weeks and underwent scintigraphic colonic transit measurements during week 8. We estimated the overall rate of colonic transit from the slope of progression of colonic geometric center over 48 hours. The capsule was activated 8 hours after ingestion, and the vibration sequence included 240 cycles. KEY RESULTS: There were no significant group differences in overall colonic transit [GC48, 2.76 (IQR 2.42-4.03) for sham group and 3.46 (2.55-4.61) for active treatment group (P=.13)]. Additionally, the progression of the isotope through the colon was numerically faster, though not significantly different (slope, P=.14) in the VIBRANT capsule group compared to the sham group. Three participants in the VIBRANT capsule group had accelerated colonic transit at 32 hours and faster colonic transit slope compared to the 95th percentile of the sham group. CONCLUSIONS AND INFERENCES: Although there were no group differences between VIBRANT and sham capsule treatment on colonic transit, at least one (and possibly three) of 12 patients receiving the VIBRANT capsule had faster colonic transit. The vibration parameters to accelerate colonic transit in patients with functional constipation require further optimization.
BACKGROUND: In an open-label study of 26 patients with IBS-C and chronic constipation, treatment with a vibrating (VIBRANT) capsule twice a week for 7.5 weeks resulted in 88.5% responders. Effects on colonic transit are unclear. We aimed to compare effects of VIBRANT and sham capsule treatment on colonic transit in patients with functional constipation. METHODS: Patients with functional constipation (Rome III criteria) were randomized to VIBRANT or sham capsule treatment for 8 weeks and underwent scintigraphic colonic transit measurements during week 8. We estimated the overall rate of colonic transit from the slope of progression of colonic geometric center over 48 hours. The capsule was activated 8 hours after ingestion, and the vibration sequence included 240 cycles. KEY RESULTS: There were no significant group differences in overall colonic transit [GC48, 2.76 (IQR 2.42-4.03) for sham group and 3.46 (2.55-4.61) for active treatment group (P=.13)]. Additionally, the progression of the isotope through the colon was numerically faster, though not significantly different (slope, P=.14) in the VIBRANT capsule group compared to the sham group. Three participants in the VIBRANT capsule group had accelerated colonic transit at 32 hours and faster colonic transit slope compared to the 95th percentile of the sham group. CONCLUSIONS AND INFERENCES: Although there were no group differences between VIBRANT and sham capsule treatment on colonic transit, at least one (and possibly three) of 12 patients receiving the VIBRANT capsule had faster colonic transit. The vibration parameters to accelerate colonic transit in patients with functional constipation require further optimization.
Authors: Lusine Ambartsumyan; Julie Khlevner; Samuel Nurko; Rachel Rosen; Ajay Kaul; John E Pandolfino; Elyanne Ratcliffe; Desale Yacob; B U K Li; Jaya Punati; Manu Sood; Satish S C Rao; Marc A Levitt; Jose T Cocjin; Leonel Rodriguez; Alejandro Flores; John M Rosen; Jaime Belkind-Gerson; Miguel Saps; Jose M Garza; John E Fortunato; Rose L Schroedl; Laurie A Keefer; Joel Friedlander; Robert O Heuckeroth; Meenakshi Rao; Khalil El-Chammas; Karla Vaz; Bruno P Chumpitazi; Rina Sanghavi; Sravan K R Matta; Tanaz Danialifar; Carlo Di Lorenzo; Anil Darbari Journal: J Pediatr Gastroenterol Nutr Date: 2020-08 Impact factor: 2.839
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