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NCT04296110 · ClinicalTrials.gov registry record · NA
Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)
A NA study, sponsored by Nationwide Children's Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT04296110: Clinical Trial NA study, sponsored by Nationwide Children's Hospital.
NCT04296110 is a NA study that was terminated before completion, run by Nationwide Children's Hospital. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04296110, a NA study, was terminated before completion, sponsored by Nationwide Children's Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Fecal calprotectin levels from stool
Interventions
- BEHAVIORAL Biofeedback
- OTHER Music Relaxation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-03-12 |
| Est. Completion | 2024-08-14 |
| Phase | NA |
Why NCT04296110 stopped before completion
NCT04296110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Biofeedback is the first listed.
NCT04296110 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04296110 about?
NCT04296110 is a clinical study titled "Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)". 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 bi...
What is the current status of trial NCT04296110?
This trial is currently terminated. It is a NA study. The enrollment target is 48 participants. The study started on 2020-03-12. Estimated completion is 2024-08-14.
What interventions are being tested in trial NCT04296110?
The interventions under investigation include: Biofeedback (BEHAVIORAL), Music Relaxation Therapy (OTHER).
Who is sponsoring clinical trial NCT04296110?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04296110's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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