Trial Outcomes & Findings for Systematic Pediatric Assessment of Rome Criteria (SPARC) (NCT NCT04773158)

Last Updated: 2025-08-07

Results Overview

This measure will be determined for the Rome IV diagnoses of: Aerophagia, Rumination, Functional Constipation, Cyclic Vomiting Syndrome (CVS), Functional Diarrhea, Non Retentive Fecal Incontinence, Functional Vomiting, Functional Nausea, Functional Dyspepsia- Postprandial Distress Subtype, Functional Dyspepsia- Epigastric Pain Syndrome Subtype, Irritable Bowel Syndrome (IBS), Abdominal Pain otherwise Not Specified, and Abdominal Migraine. The presence or absence of meeting criteria for the Rome IV diagnoses will be coded as a binary variable (true/false) to represent resolution of symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

3 months from initial diagnosis

Results posted on

2025-08-07

Participant Flow

Unit of analysis: Clinical Sites

Participant milestones

Participant milestones
Measure	Intervention Arm The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module Clinical Decision Support: The intervention clinic sites will be provided access to a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for evidence-based care recommendations for functional gastrointestinal disorders (FGIDs)	Control Arm 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.
Overall Study STARTED	21 4	12 4
Overall Study COMPLETED	17 4	10 4
Overall Study NOT COMPLETED	4 0	2 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Systematic Pediatric Assessment of Rome Criteria (SPARC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=21 Participants The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module Clinical Decision Support: The intervention clinic sites will be provided access to a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for evidence-based care recommendations for functional gastrointestinal disorders (FGIDs)	Control Arm n=12 Participants 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.	Total n=33 Participants Total of all reporting groups
Age, Continuous	7.9 years n=5 Participants	7.2 years n=7 Participants	7.9 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	12 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months from initial diagnosis

Population: Results reflect the number of participants who no longer met Rome IV Criteria coded as a binary variable "False". Of the 21 enrolled, 20 patients in the intervention group and 11 patients in the control group had a diagnosis within the Rome IV diagnoses listed. For the intervention arm, 18 of the 20 participants completed the 3 month questionnaire. For the control arm, 5 of 11 participants completed the 3 month questionnaire.

Outcome measures

Outcome measures
Measure	Intervention Arm n=18 Participants The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module Clinical Decision Support: The intervention clinic sites will be provided access to a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for evidence-based care recommendations for functional gastrointestinal disorders (FGIDs)	Control Arm n=5 Participants 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.
Resolution of Symptoms From Initial Rome IV Diagnosis at 3 Months Using an Age-appropriate Rome IV Questionnaire. Number of Participants Who no Longer Meet Rome IV Criteria.	17 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months from initial diagnosis

Population: Results reflect the number of participants with the presence of ongoing concern, coded as a binary variable true. Of 21 enrolled, 1 in the intervention group and 1 in the control group had a diagnosis within the Rome IV diagnoses listed. For each arm, 1 of 1 completed the 3 month questionnaire.

This change will be measured by a single likert scale question asked in the FGID Screening module (Baseline) and again at the 3 month follow up phone survey. , The parent is able to indicate their degree of concern about the symptomology associated with the Rome IV diagnosis. The presence or absence of ongoing concern will then be coded as a binary variable (true/false). Likert scale: Not at all concerned, Slightly concerned, Somewhat concerned, Moderately concerned, Extremely concerned

Outcome measures

Outcome measures
Measure	Intervention Arm n=1 Participants The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module Clinical Decision Support: The intervention clinic sites will be provided access to a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for evidence-based care recommendations for functional gastrointestinal disorders (FGIDs)	Control Arm n=1 Participants 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.
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. Number of Participants With Ongoing Concern.	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 1, 6 and 12 months from initial diagnosis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 and 6 months from initial diagnosis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months from initial diagnosis

Population: For intervention arm, 14 of 21 participants enrolled completed this questionnaire. For the control arm, 8 of 12 participants enrolled completed this questionnaire.

This was measured by two likert scale questions asked in the 3 month follow up phone call.

Outcome measures

Outcome measures
Measure	Intervention Arm n=14 Participants The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module Clinical Decision Support: The intervention clinic sites will be provided access to a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for evidence-based care recommendations for functional gastrointestinal disorders (FGIDs)	Control Arm n=8 Participants 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.
Parent Satisfaction With Screening Measured at 3 Months Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Very satisfied	5 participants	2 participants
Parent Satisfaction With Screening Measured at 3 Months Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Very dissatisfied	0 participants	0 participants
Parent Satisfaction With Screening Measured at 3 Months Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Dissatisfied	1 participants	0 participants
Parent Satisfaction With Screening Measured at 3 Months Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Unsure	3 participants	1 participants
Parent Satisfaction With Screening Measured at 3 Months Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Satisfied	5 participants	5 participants

SECONDARY outcome

Timeframe: 3 months from initial diagnosis

Population: For intervention arm, 14 of 21 participants enrolled completed this questionnaire. For the control arm, 8 of 12 participants enrolled completed this questionnaire.

This will be measured by two likert scale questions asked in the 3 month follow up phone call. Satisfaction with screening and treatment of FGID will be assessed.

Outcome measures

Outcome measures
Measure	Intervention Arm n=14 Participants The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module Clinical Decision Support: The intervention clinic sites will be provided access to a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for evidence-based care recommendations for functional gastrointestinal disorders (FGIDs)	Control Arm n=8 Participants 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.
Parent Satisfaction With Treatment Measured at 3 Months Will be Measured Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Unsure	5 participants	4 participants
Parent Satisfaction With Treatment Measured at 3 Months Will be Measured Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Satisfied	4 participants	2 participants
Parent Satisfaction With Treatment Measured at 3 Months Will be Measured Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Very dissatisfied	0 participants	0 participants
Parent Satisfaction With Treatment Measured at 3 Months Will be Measured Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Dissatisfied	0 participants	1 participants
Parent Satisfaction With Treatment Measured at 3 Months Will be Measured Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied] Very satisfied	5 participants	1 participants

SECONDARY outcome

Timeframe: 12 months from initial diagnosis

The following variables will be assessed: Outpatient sick visits for any complaint, Outpatient sick visits with an associated GI billing code; Visits to statewide providers, including inpatient hospital stays, outpatient clinic visits, and emergency room visits; The occurrence of any GI-related testing and procedures - specifically radiologic, laboratory testing, endoscopy, and surgical procedures related to GI diagnoses; The use of any medications prescribed to treat Rome IV diagnoses - specifically acid- suppressants, antispasmodics, antidepressants, stool softeners and laxatives, and pro-motility agents

Outcome measures

Outcome data not reported

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William E Bennett, MD

Indiana University School of Medicine, Pediatrics

Phone: 317-944-3774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place