Status:
COMPLETED
Transcutaneous VNS to Treat Pediatric IBD
Lead Sponsor:
Northwell Health
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
10-21 years
Phase:
NA
Brief Summary
The current available therapies for inflammatory bowel disease (IBD), including immunomodulator and biologic medications may have toxicities limiting use or inadequate effect. We propose a novel appro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Expectation to increase corticosteroids and/or immunosuppressive treatment
- Presence of bowel stricture with prestenotic dilatation
- Presence of intra-abdominal or perirectal abscess
- Pediatric UC activity Index (PUCAI) score ≥ 65 (severe)
- weighted Pediatric Crohn Disease Activity Index (wPCDAI) score \> 57.5 (severe)
- 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.
- Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
- 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
- Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
- Pregnancy or Lactation
- Comorbid disease with high likelihood of requiring corticosteroid use
- Inability to comply with study and follow-up procedures
- Non-English speaking
- Known cardiac condition causing or with potential to cause arrhythmia
Key Trial Info
Start Date :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03863704
Start Date
February 14 2019
End Date
December 31 2023
Last Update
October 1 2024
Active Locations (1)
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1
Steven & Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States, 11042