Irritable Bowel Syndrome (IBS)IBSNCT07283341
Diet and Motility in IBS
An observational study of Irritable Bowel Syndrome (IBS), run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The goal of this observational study is to identify factors that influence symptoms in children with irritable bowel syndrome (IBS), to find ways to make diet treatments work better and possibly create personalized plans to help each child with IBS feel better. The main question it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Wireless Patch System
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants meet the eligibility criteria listed.
Who may be able to join
- Cases:
- Males and females age 8 - 18 years
- Diagnosis of irritable bowel syndrome (IBS).
- Parental/guardian permission (informed consent) and child assent
- Controls:
- Males and Females age 8-18 years
- No diagnosis of abdominal pain disorder
- Parental/guardian permission (informed consent) and child assent
Who cannot join
- Cases:
- Allergy to adhesives
- Inability to cooperate with study design
- Antibiotic intake in the past 4 weeks
- Inflammatory gastrointestinal disorder diagnosis
- Controls:
Show all 10Show fewer
- Allergy to adhesives
- Inability to cooperate with study design
- Antibiotic intake in the past 4 weeks
- Inflammatory gastrointestinal disorder diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Alain Benitez, MD, MSTR, 215-590-1000, BenitezA@chop.edu
Binghong Xu, MD, MPH, xub3@chop.edu
About this study
Official title: The Role of Diet and Gastrointestinal Motility in Irritable Bowel Syndrome (IBS)
The goal of this observational study is to identify factors that influence symptoms in children with irritable bowel syndrome (IBS), to find ways to make diet treatments work better and possibly create personalized plans to help each child with IBS feel better. The main question it aims to answer is:
- What types of food do the kids eat and how do these diets relate to their symptoms?
- Is there any motility pattern that we can identify from the kids with or without IBS using a wearable patch?
- What kinds of bacteria and chemicals are found in the gut and urine of children with IBS, and how are these linked to their IBS symptoms?
Participants will use the wearable patch, answer questionnaires, collect stool and urine samples, and recall their 24 hours dietary.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Wireless Patch System
- Keywords
- Irritable Bowel Syndrome, Diet, Motility, Wireless Patch System
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless Patch SystemDiagnostic test
The Wireless Patch System will be placed on the abdominal skin. Participants will receive an iPhone containing the WPS app to record symptoms and meals. Participants undergoing a clinically indicated dietary intervention will complete study procedures before and after the dietary intervention.
| Study group | Role | What they receive |
|---|---|---|
| IBS Cohort | Participants ages 8 to 18 years old who meet Rome IV diagnostic criteria for IBS Receives: Diagnostic Test: Wireless Patch System | |
| Control Cohort | Participants ageds 8-18 years old who don't have IBS Receives: Diagnostic Test: Wireless Patch System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS)
Differences in total activity, pre- and post-prandial activity ratios, nighttime colonic activity, and night-to-day colonic activity ratios between IBS patients and controls. WPS reading will be completed after each study visit. Differences will be compared at the 3rd and 4th quarters of each year.
Measured: Approximately one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start31 Jul 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Benitez, MD, MSTR, Principal investigator, Children's Hospital of Philadelphia, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283341
- Sponsor's protocol ID
- 22-020433
- Acronym
- IBS
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Axelrod L, Axelrod S, Navalgund A, Triadafilopoulos G. Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic and Disease Correlations. Dig Dis Sci. 2021 Oct;66(10):3505-3515. doi: 10.1007/s10620-020-06663-y. Epub 2020 Oct 15.
PubMed 33063188
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Diet and Gastrointestinal Motility in Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT07283341
- Acronym / sponsor ID
- IBS / 22-020433
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Irritable Bowel Syndrome, Diet, Motility, Wireless Patch System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to identify factors that influence symptoms in children with irritable bowel syndrome (IBS), to find ways to make diet treatments work better and possibly create personalized plans to help each child with IBS feel better. The main question it aims to answer is:
- What types of food do the kids eat and how do these diets relate to their symptoms?
- Is there any motility pattern that we can identify from the kids with or without IBS using a wearable patch?
- What kinds of bacteria and chemicals are found in the gut and urine of children with IBS, and how are these linked to their IBS symptoms?
Participants will use the wearable patch, answer questionnaires, collect stool and urine samples, and recall their 24 hours dietary.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS Cohort | – | Diagnostic Test: Wireless Patch SystemParticipants ages 8 to 18 years old who meet Rome IV diagnostic criteria for IBS |
| Control Cohort | – | Diagnostic Test: Wireless Patch SystemParticipants ageds 8-18 years old who don't have IBS |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants meet the eligibility criteria listed.
Key inclusion criteria (8 listed)
- Males and females age 8 - 18 years
- Diagnosis of irritable bowel syndrome (IBS).
- Parental/guardian permission (informed consent) and child assent
- Males and Females age 8-18 years
- No diagnosis of abdominal pain disorder
Key exclusion criteria (10 listed)
- Allergy to adhesives
- Inability to cooperate with study design
- Antibiotic intake in the past 4 weeks
- Inflammatory gastrointestinal disorder diagnosis
- Allergy to adhesives
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 |
|---|---|---|
| Wireless Patch SystemThe Wireless Patch System will be placed on the abdominal skin. Participants will receive an iPhone containing the WPS app to record symptoms and meals. Participants undergoing a clinically indicated dietary intervention will complete study procedures before and after the dietary intervention. | Diagnostic test | Control Cohort, IBS Cohort |
Primary outcome
Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS)
Time frame: Approximately one year.
Differences in total activity, pre- and post-prandial activity ratios, nighttime colonic activity, and night-to-day colonic activity ratios between IBS patients and controls. WPS reading will be completed after each study visit. Differences will be compared at the 3rd and 4th quarters of each year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 33063188Axelrod L, Axelrod S, Navalgund A, Triadafilopoulos G. Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic and Disease Correlations. Dig Dis Sci. 2021 Oct;66(10):3505-3515. doi: 10.1007/s10620-020-06663-y. Epub 2020 Oct 15.
- Individual participant dataSharing planned: Undecided
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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.
Alain Benitez, MD, MSTR principal investigator
Children's Hospital of Philadelphia, University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome (IBS), run by Children's Hospital of Philadelphia 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain Benitez, MD, MSTR (215-590-1000, BenitezA@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS) (time frame: Approximately one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07283341, which also lists 1 linked publication.
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 15 Dec 2025.