Clinical Decision Support for Functional Gastrointestinal Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Functional Gastrointestinal Disorders+2 More
Clinical Decision Support - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

This trial will test whether a Clinical Decision Support System can help gastroenterologists more accurately diagnose and treat Functional gastrointestinal disorders in children.

Eligible Conditions
  • Functional Gastrointestinal Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: 1, 6 and 12 months from initial diagnosis

Month 6
Change in parental concern (for the Rome IV diagnoses of Infant Regurgitation, Infant Dyschezia, and/or Infant Colic from initial Rome IV diagnosis at 1 an 6 months using likert scale questionnaire
Dyschezia
Month 12
Resolution of symptoms from initial Rome IV diagnosis at 1, 6 and 12 months using an age-appropriate Rome IV questionnaire.
Month 12
Rate of health care utilization will be assessed 12 months after initial Rome IV Screening positive. Variables will be coded as binary variables (true/false)
Month 3
Parent Satisfaction will be measured using a likert scale questionnaire
Resolution of symptoms from initial Rome IV diagnosis at 3 months using an age-appropriate Rome IV questionnaire.
Month 3
Change in parental concern (for the Rome IV diagnoses of Infant Regurgitation, Infant Dyschezia, and/or Infant Colic from initial Rome IV diagnosis at 3 months using likert scale questionnaire
Change in parental concern (for the Rome IV diagnoses of infant regurgitation, infant dyschezia, and/or infant colic) from initial Rome IV diagnosis at 3 months using likert scale questionnaire

Trial Safety

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Intervention Arm
1 of 2

Active Control

Experimental Treatment

600 Total Participants · 2 Treatment Groups

Primary Treatment: Clinical Decision Support · No Placebo Group · N/A

Intervention Arm
Behavioral
Experimental Group · 1 Intervention: Clinical Decision Support · Intervention Types: Behavioral
Control ArmNoIntervention Group · 1 Intervention: Control Arm · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clinical Decision Support
2019
N/A
~35540

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 6 and 12 months from initial diagnosis

Who is running the clinical trial?

Indiana UniversityLead Sponsor
870 Previous Clinical Trials
748,337 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,125 Previous Clinical Trials
4,062,518 Total Patients Enrolled
William E Bennett, MDPrincipal InvestigatorIndiana University School of Medicine
2 Previous Clinical Trials
146 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.