Transcutaneous VNS to Treat Pediatric IBD

Korábbi kezelés

• Expectation to increase corticosteroids and/or immunosuppressive treatment
• Active treatment with antibiotics
• Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
• Continuous treatment with an anti-cholinergic medication, including over the counter medications
• Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
• Bowel resection surgery within past 90 days prior to study enrollment and on no conventional IBD therapy, or planned surgery within the course of the study
• Any planned surgical procedure requiring general anesthesia within the course of the study
• Participation in any other Investigational drug and/or treatment currently or planned during the length of the study

Más betegség

• weighted Pediatric Crohn Disease Activity Index (wPCDAI) score > 57.5 (severe)
• Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
• Comorbid disease with high likelihood of requiring corticosteroid use
• Known cardiac condition causing or with potential to cause arrhythmia

Egyéb

• Presence of bowel stricture with prestenotic dilatation
• Presence of intra-abdominal or perirectal abscess
• Pediatric UC activity Index (PUCAI) score ≥ 65 (severe)
• Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
• Pregnancy or Lactation
• Inability to comply with study and follow-up procedures
• Non-English speaking

• Age 10-21 years
• IBD diagnosis for at least 3 months, confirmed by clinical, biochemical, and endoscopic evaluations
• Elevated Fecal calprotectin ≥ 200 ug/g within the past 4 weeks prior to enrollment
• Evidence of active inflammatory disease despite treatment with at least one conventional therapy
• If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study
• If on 5-Aminosalicylate, dose must be stable with following parameters:
  • 28 days on oral medication
  • Prior to baseline calprotectin, 28 days on rectal medication or 2 weeks off rectal medication
• If on background immunosuppressive treatment the dose must be stable with the following parameters:
  • 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine)
  • 112 days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, other biologic
• Able and willing to give written informed consent and comply with the requirements of the study protocol.