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Clinical Decision Support for Functional Gastrointestinal Disorders (SPARC Trial)

N/A
Recruiting
Led By William E Bennett, MD
Research Sponsored by Indiana University
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 1, 6 and 12 months from initial diagnosis
Awards & highlights

SPARC Trial Summary

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

Who is the study for?
This trial is for children aged 0-17 with gastrointestinal issues, seen at pediatric primary care clinics in the Eskenazi health system, and their doctors. There are no exclusions, meaning all such patients and physicians can participate.Check my eligibility
What is being tested?
The study tests a Clinical Decision Support System (CDSS) that helps doctors diagnose and treat functional gastrointestinal disorders using updated guidelines. It's a randomized trial where some clinics get both diagnosis and treatment modules, while others only get the diagnosis module.See study design
What are the potential side effects?
Since this intervention involves a decision support tool rather than medication or surgery, traditional side effects aren't expected. However, there may be indirect effects on patient care depending on the system's accuracy.

SPARC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 6 and 12 months from initial diagnosis
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6 and 12 months from initial diagnosis for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Resolution of symptoms from initial Rome IV diagnosis at 3 months using an age-appropriate Rome IV questionnaire.
Secondary outcome measures
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
Parent Satisfaction will be measured using a likert scale questionnaire
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)
+1 more

SPARC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module
Group II: Control ArmActive Control1 Intervention
The control clinics will have the Functional gastrointestinal disorders (FGIDs) Screening Module. However, control clinics will not have access to the FGIDs Treatment Module. These clinic sites will be given access to the pre-screener form section of the module, so that providers are made aware of a positive screen for a FGID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clinical Decision Support
2019
N/A
~37100

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,313,991 Total Patients Enrolled
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,676 Total Patients Enrolled
William E Bennett, MDPrincipal InvestigatorIndiana University School of Medicine
2 Previous Clinical Trials
146 Total Patients Enrolled

Media Library

Clinical Decision Support Clinical Trial Eligibility Overview. Trial Name: NCT04773158 — N/A
Functional Gastrointestinal Disorders Research Study Groups: Intervention Arm, Control Arm
Functional Gastrointestinal Disorders Clinical Trial 2023: Clinical Decision Support Highlights & Side Effects. Trial Name: NCT04773158 — N/A
Clinical Decision Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT04773158 — 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 any current opportunities to join this clinical research project?

"Yes, according to clinicaltrials.gov records this research endeavour is currently recruiting participants for its trials. It was first advertised on November 22nd 2021 and has been recently updated on August 8th 2022. 600 volunteers are needed from a single site to complete the study's objectives."

Answered by AI

What aims is this trial attempting to achieve?

"This medical study's primary outcome entails evaluating the resolution of symptoms from a Rome IV diagnosis at 3 months. Subjects will also be assessed for symptom resolution 1, 6 and 12 months after initial diagnoses. Secondary outcomes include change in parental concern (for Infant Regurgitation, Dyschezia, and Colic) measured by likert scale questionnaires as well as parent satisfaction with screening and treatment evaluation using another set of likert scales questions."

Answered by AI

How many participants are allowed to take part in this experiment?

"Affirmative. The particulars found on clinicaltrials.gov denote that this medical trial is presently inviting enrollees; it was posted to the website on November 22nd 2021 and recently updated on August 8th 2022. 600 individuals are being recruited for participation at a single site."

Answered by AI

To whom is this trial available?

"This clinical trial requires 600 participants with functional gastrointestinal disorders aged between 1 Day and 17 years old. Eligibility criteria dictate that all applicants must be seen in the Eskenazi health system's paediatric primary care clinic by a Primary Care Physician."

Answered by AI

Does this clinical trial encompass individuals who are over the age of fifty-five?

"As indicated by the study's inclusion parameters, children of any age starting from 1 day old up to 17 years can be eligible for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Systematic Pediatric Assessment of Rome Criteria
William E. Bennett, Jr. 2021. "Systematic Pediatric Assessment of Rome Criteria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04773158.
~88 spots leftby Sep 2024
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