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Biofeedback for Inflammatory Bowel Disease

N/A

Waitlist Available

Led By Ross Maltz, MD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to 12 month follow up

Awards & highlights

Study Summary

This trial will compare the effects of two different therapies for Crohn's disease in children. One group will receive biofeedback training to help them control their heart rate variability, while the other group will receive music relaxation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to 12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to 12 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety

Depression

Disease Activity (Crohn's disease)

+3 more

Secondary outcome measures

Stress-related changes in the metabolome.

Stress-related changes in the microbiome

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BiofeedbackExperimental Treatment1 Intervention

Participants will receive a biofeedback intervention. They will be asked to practice breathing at their designated resonance frequency using provided biofeedback device daily for 12 weeks.

Group II: ControlActive Control1 Intervention

Participants will receive music relaxation therapy. They will be asked to listen to designated music daily for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biofeedback

2016

Completed Phase 4

~1280

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,423 Total Patients Enrolled

Ross Maltz, MD3.45 ReviewsPrincipal Investigator - Nationwide Childrens Hospital

Nationwide Children's Hospital

1 Previous Clinical Trials

1Patient Review

Dr. Maltz was unfortunately unhelpful and dismissive of my child's issues. We would have never known the extent of the problem if we had stopped at his office — he downplayed every sign and symptom. It was a waste of time and effort. I do not recommend him, especially given that he works at Nationwide Children's Hospital.

Media Library

Biofeedback Clinical Trial Eligibility Overview. Trial Name: NCT04296110 — N/A

Inflammatory Bowel Disease Research Study Groups: Control, Biofeedback

Inflammatory Bowel Disease Clinical Trial 2023: Biofeedback Highlights & Side Effects. Trial Name: NCT04296110 — N/A

Biofeedback 2023 Treatment Timeline for Medical Study. Trial Name: NCT04296110 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there remaining vacancies within this clinical experiment?

"Affirmative. Clinicaltrial.gov reveals that this clinical experiment has been open to recruitment since March 12th 2020 and was refreshed on July 19th 2022, with the aim of enrolling 80 volunteers across one site."

Answered by AI

Is this research endeavor open to people aged 80 and above?

"This trial allows participants aged 8-17 years, respecting the parameters of its inclusion criteria."

Answered by AI

How many individuals are participating in the clinical trial?

"Affirmative. According to clinicaltrials.gov, recruitment efforts for this medical trial are still underway - it was initially posted on March 12th 2020 and last modified on July 19th 2022. This research seeks 80 individuals from a single medical centre."

Answered by AI

Does my profile meet the eligibility requirements for this clinical trial?

"This investigation seeks to recruit 80 minors between 8 and 17 years of age who suffer from IBD. To be eligible, these children must meet the following criteria: Age 8-17 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)

Ross Maltz 2020. "Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04296110.