Adults 12 to 18, any sex, with Functional Gastrointestinal Disorders or Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To Measure Different Mitochondrial Bioenergetic Markers, Including Basal Respiratory CapacityPrimary· Baseline, at follow-up visit 4 (Week 4) and at follow up visit 5 (Week 8 or 12)
Blood draw will be tested for mitochondrial function, including basal respiratory capacity, ATP production and spare respiration and to detect changes in protein which can be an indicator for inflammation. Basal Respiratory Capacity (pmol/min) is better when value is higher.
Week 1
Group
Value
95% CI
Only Active Devise, Open Label
221.85
± 195.35
Week 4
Group
Value
95% CI
Only Active Devise, Open Label
151.14
± 101.97
Week 8
Group
Value
95% CI
Only Active Devise, Open Label
139.20
± 120.12
To Measure Heart Rate VariabilitySecondary· At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and 5 (Week 8 or 12)
EKG tracing will be used to analyze Heart Rate Variability as an indirect measure of vagal nerve output and central autonomic control.
Week 1
Group
Value
95% CI
Only Active Devise, Open Label
100.31
± 17.31
Week 4
Group
Value
95% CI
Only Active Devise, Open Label
97.27
± 21.69
Week 8
Group
Value
95% CI
Only Active Devise, Open Label
93.86
± 15.63
Total
Group
Value
95% CI
Only Active Devise, Open Label
97.35
± 18.17
To Measure Functional Disability InventorySecondary· At date of baseline assessment (beginning of therapy). Also assessed at follow-up visit 4 (Week 4) and visit 5 (8 or 12)
The Functional Disability Inventory (FDI) questionnaire will be used to assess change in symptoms. Participants will rank physical trouble or difficulty completing 15 different daily activities (Eating regular meals, Being at school all day, Walking up stairs, etc.) on a scale of 0-4.
Scale:0-No trouble
1. A little trouble
2. Some Trouble
3. A lot of Trouble
4. Impossible
Higher scores (4) indicate more difficulty functioning due to physical health. The total score ranges from 0 to 60 among 15 questions. The individual score for all 15 questions are added together for the total score. If al
Week 1
Group
Value
95% CI
Only Active Devise, Open Label
26.53
± 14.04
Week 4
Group
Value
95% CI
Only Active Devise, Open Label
24.58
± 15.25
Week 8
Group
Value
95% CI
Only Active Devise, Open Label
22.70
± 17.47
Total
Group
Value
95% CI
Only Active Devise, Open Label
24.74
± 14.60
Sponsor's own description
This study evaluates the effect of auricular neurostimulation on mitochondrial bioenergetics and inflammation through vagal nerve modulation via non-invasive percutaneous electrical nerve field stimulator in children with functional gastrointestinal disorders.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 21 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03931330.