The following article is a part of conference coverage from the Advances in Inflammatory Bowel Diseases 2021 Annual Meeting , held from December 9 to 11, 2021. The team at Gastroenterology Advisor will be reporting on the latest news and research conducted by leading experts in gastroenterology. Check back for more from AIBD 2021.
Vagal nerve stimulation (VNS) may improve symptoms in children and young adults with inflammatory bowel disease (IBD), according to research presented at the Advances in Inflammatory Bowel Diseases (AIBD) 2021 Annual Meeting, held from December 9 to 11, 2021, in Orlando, Florida and virtually.
This proof-of-concept study enrolled patients aged 10 to 21 years with mild to moderate Crohn disease or ulcerative colitis who did not achieve remission with conventional therapy. Eligible patients had fecal calprotectin (FC) levels ≥200 μg/g within 4 weeks of study entry.
Patients were randomly assigned to receive either transcutaneous auricular VNS (ta-VNS) using a cutaneous electrical nerve stimulator unit targeting the left ear or sham stimulation of the posterior lower leg for 5 minutes once-daily for 2 weeks. Patients were then switched to the alternate condition for an additional 2 weeks, after which they each received active ta-VNS for 5 minutes twice-daily until week 16.
The primary study endpoints were reduction in disease activity and reduction in FC levels. Disease activity was assessed using the weighted Pediatric Crohn Disease Activity Index (wPCDAI) or Pediatric Ulcerative Colitis Activity Index (PUCAI).
Twenty-two patients were enrolled, among whom 54.5% had ulcerative colitis, and 45.5% had Crohn disease. Median age was 14.4 years and half of participants (54.5%) were boys. Median baseline FC was 587 μg/g (range, 18-3828 μg/g).
Among the 6 patients with ulcerative colitis and PUCAI scores >10 at baseline, 2 achieved clinical remission at week 16. An additional 3 patients with Crohn disease achieved remission (wPCDAI ≤ 10) at week 16. No safety signals were observed.
Results from this exploratory study suggest that noninvasive ta-VNS may reduce FC levels and improve clinical outcomes in pediatric patients with mild to moderate IBD. Further studies are necessary to identify the optimal ta-VNS dose and schedule for clinical effect.
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Sahn B, Pascuma K, Tracey K, Markowitz J. Non-invasive vagal nerve stimulation to treat Crohn disease and ulcerative colitis in children and young adults: a proof-of-concept clinical trial. Presented at: AIBD 2021 Annual Meeting; December 9-11, 2021; Orlando, FL and virtual. Abstract P072.