Recruiting

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07283341

Conditions

Irritable Bowel Syndrome (IBS)

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Accepted

Interventions

Wireless Patch System

Study Details

Brief 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. What types of food do the kids eat and how do these diets relate to their symptoms?
2. Is there any motility pattern that we can identify from the kids with or without IBS using a wearable patch?
3. 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)

Study ID

NCT07283341

Start date

Jul 31, 2023

Status verified date

Dec, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

Cases:

1. Males and females age 8 - 18 years
2. Diagnosis of irritable bowel syndrome (IBS).
3. Parental/guardian permission (informed consent) and child assent

Controls:

1. Males and Females age 8-18 years
2. No diagnosis of abdominal pain disorder
3. Parental/guardian permission (informed consent) and child assent

Exclusion Criteria:

Cases:

1. Allergy to adhesives
2. Inability to cooperate with study design
3. Antibiotic intake in the past 4 weeks
4. Inflammatory gastrointestinal disorder diagnosis

Controls:

1. Allergy to adhesives
2. Inability to cooperate with study design
3. Antibiotic intake in the past 4 weeks
4. Inflammatory gastrointestinal disorder diagnosis

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

IBS Cohort

Participants ages 8 to 18 years old who meet Rome IV diagnostic criteria for IBS

Control Cohort

Participants ageds 8-18 years old who don't have IBS

Interventions

Wireless Patch System

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.

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. ]

Central Contacts and Locations

Central contacts

Alain Benitez, MD, MSTR

215-590-1000BenitezA@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alain Benitez, MD, MSTR

215-590-1000BenitezA@chop.edu

Binghong Xu, MD, MPH

xub3@chop.edu

Principal Investigator:

Alain Benitez, MD, MSTR

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Irritable Bowel Syndrome
  • Diet
  • Motility
  • Wireless Patch System

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2025-12-15.