Last reviewed · How we verify
NCT04296110
Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)
NA trial testing Biofeedback in IBD in 48 participants. Terminated before completion.
14 August 2024
Quick facts
| Lead sponsor | Nationwide Children's Hospital |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 12 March 2020 |
| Primary completion | 14 August 2024 |
| Estimated completion | 14 August 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Biofeedback
- Music Relaxation Therapy
Conditions studied
- IBD — all drugs for IBD →
Sponsor
Nationwide Children's Hospital
Who can join
Adults 8 to 17, any sex, with IBD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This prospective, randomized, longitudinal, controlled study will enroll pediatric CD patients with inflammatory, non-stricturing, and non-penetrating disease type with mild/quiescent disease based on Pediatric Crohn's Disease Activity Index (PCDAI). Participants will be randomized to receive HRV biofeedback intervention daily for 12 weeks or to music relaxation therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04296110
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Biofeedback
Trials testing the same drug.
- NCT07095283 — Second-generation Radiofrequency Application and Therapeutic Exercise for Stress Urinary Incontinence · NA · completed
- NCT06532292 — Physical Therapy Intervention for Pelvic Organ Prolapses · NA · recruiting
- NCT06150638 — Treatment of Functional Abdominal Distension by Non-instrumental Biofeedback · NA · completed
- NCT06273046 — Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback · NA · recruiting
- NCT06034119 — Effects of Voluntary Adjustments During Walking in Participants Post-stroke · NA · completed
Other recruiting trials for IBD
Currently open trials in the same condition.
- NCT07385807 — Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Out · recruiting
- NCT07271264 — A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endo · NA · recruiting
- NCT07224113 — Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD · recruiting
- NCT07195123 — Evaluation of the SMART IBD App in Pediatric IBD · NA · recruiting
- NCT07380022 — Acceptability, Adherence, and Impact on the Bioavailability of Iron and Zinc of the Dietary Supplements Goodphyte IB Def · NA · recruiting
Other Nationwide Children's Hospital trials
Trials by the same sponsor.
- NCT07035912 — Novel PIONEER© Protocol: RCT · NA · not yet recruiting
- NCT07435792 — TetraGraph to Evaluate Onset and Recovery Times of Rocuronium · NA · not yet recruiting
- NCT07026942 — Phase I/II Clinical Trial of Universal Donor CD33 CAR Natural Killer Cells for AML · Phase 1, PHASE2 · not yet recruiting
- NCT06795126 — Little NIRVANA for Pediatric Pain and Anxiety · NA · enrolling by invitation
- NCT06854991 — Healthy Children and Virtual Reality Mediation of Simulated Pain · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04296110 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nationwide Children's Hospital
- Last refreshed: 15 August 2024
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/NCT04296110.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing