Functional Gastrointestinal DisordersSPARCNCT04773158
Systematic Pediatric Assessment of Rome Criteria (SPARC)
A study testing Clinical Decision Support in people with Functional Gastrointestinal Disorders, run by Indiana University at 1 site in United States.
Trial summary
While gastroenterologists care for many of the pediatric patients with Functional gastrointestinal disorders (FGIDs), the majority of the burden continues to be borne by general pediatricians, especially with respect to initial diagnosis. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Clinical Decision Support
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2021to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any patient between the ages of 0 through 17 presenting to a pediatric primary care clinic in the Eskenazi health system and the Primary Care Physician who sees them
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematic Pediatric Assessment of Rome Criteria
While gastroenterologists care for many of the pediatric patients with Functional gastrointestinal disorders (FGIDs), the majority of the burden continues to be borne by general pediatricians, especially with respect to initial diagnosis. Unfortunately, FGIDs are often diagnosed incorrectly by primary care providers, and patients often wait months to years before a correct diagnosis is made, and effective treatment is begun. Furthermore, primary care providers are often unaware of recent guideline changes or the evidence base for children with FGIDs, leading to overuse of testing, inappropriate or ineffective treatment, and increased costs. Given this information, it is essential that we develop interventions that target pediatric primary care providers to improve their care for children with FGIDs. The investigators propose that using a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for diagnosis and evidence-based care for FGIDs will improve the (1) accuracy of diagnosis and (2)_ effectiveness of clinical care. A CDSS has advantages with respect to guideline adherence and automated diagnosis, because it can provide focused, real-time, patient-specific data to the clinician. The investigators hypothesize that automation of screening, diagnosis, and management of FGIDs using the Rome IV criteria will result in improved resolution of FGIDs (primary outcome), as well as decreased utilization of medical services (secondary outcomes). This hypothesis will be tested utilizing a randomized controlled trial. The intervention clinic sites will be provided access to both the FGIDs Screening Module and the Treatment Module. The control clinics will have the 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.
Read the detailed description
Functional gastrointestinal disorders (FGIDs) are extremely common in children and adolescents, and represent a wide range of disorders that are related to the gastrointestinal tract, but have no clear structural, anatomic, or histopathologic cause. FGIDs represent an enormous burden on patients and families, and patients with these functional disorders have much higher health care utilization and related costs. As there are no biochemical markers or structural abnormalities that can be used to diagnose these disorders in children objectively, FGIDs are diagnosed according to the symptom-based Rome criteria. While gastroenterologists care for many of the pediatric patients with FGIDs, the majority of the burden continues to be borne by general pediatricians, especially with respect to initial diagnosis. Unfortunately, FGIDs are often diagnosed incorrectly by primary care providers, and patients often wait months to years before a correct diagnosis is made, and effective treatment is begun. Furthermore, primary care providers are often unaware of recent guideline changes or the evidence base for children with FGIDs, leading to overuse of testing, inappropriate or ineffective treatment, and increased costs. Given this information, it is essential to develop interventions that target pediatric primary care providers to improve their care for children with FGIDs. This study proposes that using a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for diagnosis and evidence-based care for FGIDs will improve the (1) accuracy of diagnosis and (2)_ effectiveness of clinical care. A CDSS has advantages with respect to guideline adherence and automated diagnosis, because it can provide focused, real-time, patient-specific data to the clinician. Studies of barriers to guideline implementation have shown multiple factors at work: unfamiliarity with a guideline, lack of self-efficacy, or difficulty implementing the guideline components within the current workflow of a practice. CDSS can overcome many of these barriers because they are integrated with systems that routinely store and retrieve patient information and can improve workflow by providing clinicians with patient-specific advice at the time of the patient visit. The study investigators hypothesize that automation of screening, diagnosis, and management of FGIDs using the Rome IV criteria will result in improved resolution of FGIDs (primary outcome), as well as decreased utilization of medical services (secondary outcomes). This hypothesis will be tested utilizing a randomized controlled trial. The intervention clinic sites will be provided access to both the FGIDs Screening Module and the Treatment Module. The control clinics will have the 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. The investigators have chosen not to have an arm without provider notification due to concern that identification of symptoms without notifying the patient's provider represented an ethical concern. If anything, this will bias towards a null result. Since FGIDs have both a high rate of relapse, and a high rate of spontaneous resolution, it is necessary to assess the pattern of symptoms across multiple time points. As such, we plan to gather various data from parents/patients at 1, 3, 6 and 12-months via phone interview. Additionally, the study will assess parental satisfaction with the screening and treatment of their child's particular FGID at the 3-month phone interview. For assessment of health care utilization, the study will look at the following variables in the 12 months after initial Rome IV screening positive: a) outpatient sick visits for any complaint; b) outpatient sick visits with an associated GI billing code; c) visits to statewide providers, including inpatient hospital stays, outpatient clinic visits, and emergency room visits; d) GI-related testing and procedures; e) use of any medications prescribed to treat Rome IV diagnoses. These data will be obtained from multiple sources including the EMR, and Indiana Network for Patient Care (INPC).
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Clinical Decision Support
- Keywords
- Computerized Decision Support
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision SupportBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module Receives: Behavioral: Clinical Decision Support |
| Control Arm | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 3 months from initial diagnosis
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.
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
Measured: Baseline and 3 months from initial diagnosis
Secondary outcomes (7)
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
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
Measured: 1 and 6 months from initial diagnosis
Parent Satisfaction With Screening Measured at 3 Months Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied]
This was measured by two likert scale questions asked in the 3 month follow up phone call.
Measured: 3 months from initial diagnosis
Parent Satisfaction With Treatment Measured at 3 Months Will be Measured Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied]
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.
Measured: 3 months from initial diagnosis
Resolution of Symptoms From Initial Rome IV Diagnosis at 1 Month Using an Age-appropriate Rome IV Questionnaire.
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.
Measured: 1 months from initial diagnosis
Resolution of Symptoms From Initial Rome IV Diagnosis at 6 Months Using an Age-appropriate Rome IV Questionnaire.
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.
Measured: 6 months from initial diagnosis
Resolution of Symptoms From Initial Rome IV Diagnosis at 12 Months Using an Age-appropriate Rome IV Questionnaire.
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.
Measured: 12 months from initial diagnosis
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)
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
Measured: 12 months from initial diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start22 Nov 2021
- Primary completion14 May 2024
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Will perform cluster randomization by clinic. The unit of randomization will be the clinic site, but the unit of analysis will be the individual patient.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William E. Bennett, Jr., Indiana University
- Investigators
- William E Bennett, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773158
- Sponsor's protocol ID
- 1811325201
- Other IDs
- R01DK118433
- Acronym
- SPARC
- Status last verified
- Feb 2026
- First submitted
- 11 May 2020
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Pediatric Assessment of Rome Criteria
- ClinicalTrials.gov ID
- NCT04773158
- Acronym / sponsor ID
- SPARC / 1811325201
- Conditions
- Functional Gastrointestinal Disorders
- Keywords
- Computerized Decision Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 7 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While gastroenterologists care for many of the pediatric patients with Functional gastrointestinal disorders (FGIDs), the majority of the burden continues to be borne by general pediatricians, especially with respect to initial diagnosis. Unfortunately, FGIDs are often diagnosed incorrectly by primary care providers, and patients often wait months to years before a correct diagnosis is made, and effective treatment is begun. Furthermore, primary care providers are often unaware of recent guideline changes or the evidence base for children with FGIDs, leading to overuse of testing, inappropriate or ineffective treatment, and increased costs. Given this information, it is essential that we develop interventions that target pediatric primary care providers to improve their care for children with FGIDs. The investigators propose that using a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for diagnosis and evidence-based care for FGIDs will improve the (1) accuracy of diagnosis and (2)_ effectiveness of clinical care. A CDSS has advantages with respect to guideline adherence and automated diagnosis, because it can provide focused, real-time, patient-specific data to the clinician. The investigators hypothesize that automation of screening, diagnosis, and management of FGIDs using the Rome IV criteria will result in improved resolution of FGIDs (primary outcome), as well as decreased utilization of medical services (secondary outcomes). This hypothesis will be tested utilizing a randomized controlled trial. The intervention clinic sites will be provided access to both the FGIDs Screening Module and the Treatment Module. The control clinics will have the 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.
Detailed description
Functional gastrointestinal disorders (FGIDs) are extremely common in children and adolescents, and represent a wide range of disorders that are related to the gastrointestinal tract, but have no clear structural, anatomic, or histopathologic cause. FGIDs represent an enormous burden on patients and families, and patients with these functional disorders have much higher health care utilization and related costs. As there are no biochemical markers or structural abnormalities that can be used to diagnose these disorders in children objectively, FGIDs are diagnosed according to the symptom-based Rome criteria. While gastroenterologists care for many of the pediatric patients with FGIDs, the majority of the burden continues to be borne by general pediatricians, especially with respect to initial diagnosis. Unfortunately, FGIDs are often diagnosed incorrectly by primary care providers, and patients often wait months to years before a correct diagnosis is made, and effective treatment is begun. Furthermore, primary care providers are often unaware of recent guideline changes or the evidence base for children with FGIDs, leading to overuse of testing, inappropriate or ineffective treatment, and increased costs. Given this information, it is essential to develop interventions that target pediatric primary care providers to improve their care for children with FGIDs. This study proposes that using a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for diagnosis and evidence-based care for FGIDs will improve the (1) accuracy of diagnosis and (2)_ effectiveness of clinical care. A CDSS has advantages with respect to guideline adherence and automated diagnosis, because it can provide focused, real-time, patient-specific data to the clinician. Studies of barriers to guideline implementation have shown multiple factors at work: unfamiliarity with a guideline, lack of self-efficacy, or difficulty implementing the guideline components within the current workflow of a practice. CDSS can overcome many of these barriers because they are integrated with systems that routinely store and retrieve patient information and can improve workflow by providing clinicians with patient-specific advice at the time of the patient visit. The study investigators hypothesize that automation of screening, diagnosis, and management of FGIDs using the Rome IV criteria will result in improved resolution of FGIDs (primary outcome), as well as decreased utilization of medical services (secondary outcomes). This hypothesis will be tested utilizing a randomized controlled trial. The intervention clinic sites will be provided access to both the FGIDs Screening Module and the Treatment Module. The control clinics will have the 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. The investigators have chosen not to have an arm without provider notification due to concern that identification of symptoms without notifying the patient's provider represented an ethical concern. If anything, this will bias towards a null result. Since FGIDs have both a high rate of relapse, and a high rate of spontaneous resolution, it is necessary to assess the pattern of symptoms across multiple time points. As such, we plan to gather various data from parents/patients at 1, 3, 6 and 12-months via phone interview. Additionally, the study will assess parental satisfaction with the screening and treatment of their child's particular FGID at the 3-month phone interview. For assessment of health care utilization, the study will look at the following variables in the 12 months after initial Rome IV screening positive: a) outpatient sick visits for any complaint; b) outpatient sick visits with an associated GI billing code; c) visits to statewide providers, including inpatient hospital stays, outpatient clinic visits, and emergency room visits; d) GI-related testing and procedures; e) use of any medications prescribed to treat Rome IV diagnoses. These data will be obtained from multiple sources including the EMR, and Indiana Network for Patient Care (INPC).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Will perform cluster randomization by clinic. The unit of randomization will be the clinic site, but the unit of analysis will be the individual patient.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Clinical Decision SupportThe intervention clinic sites will be provided access to both the Functional gastrointestinal disorders (FGIDs) Screening Module and the Treatment Module |
| Control Arm | No 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. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any patient between the ages of 0 through 17 presenting to a pediatric primary care clinic in the Eskenazi health system and the Primary Care Physician who sees them
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision SupportThe 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) | Behavioural | Intervention Arm |
Primary outcome
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.
Time frame: 3 months from initial diagnosis
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.
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.
Time frame: Baseline and 3 months from initial diagnosis
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
7 secondary outcomes
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
Time frame: 1 and 6 months from initial diagnosis
Parent Satisfaction With Screening Measured at 3 Months Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied]
Time frame: 3 months from initial diagnosis
Parent Satisfaction With Treatment Measured at 3 Months Will be Measured Using a Likert Scale Questionnaire [Very Dissatisfied , Dissatisfied, Unsure, Satisfied, Very Satisfied]
Time frame: 3 months from initial diagnosis
Resolution of Symptoms From Initial Rome IV Diagnosis at 1 Month Using an Age-appropriate Rome IV Questionnaire.
Time frame: 1 months from initial diagnosis
Resolution of Symptoms From Initial Rome IV Diagnosis at 6 Months Using an Age-appropriate Rome IV Questionnaire.
Time frame: 6 months from initial diagnosis
Resolution of Symptoms From Initial Rome IV Diagnosis at 12 Months Using an Age-appropriate Rome IV Questionnaire.
Time frame: 12 months from initial diagnosis
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)
Time frame: 12 months from initial diagnosis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Bennett, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support in people with Functional Gastrointestinal Disorders, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 months from initial diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.