Diet and Motility in IBS (IBS)

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Diagnostic test: Wireless Patch System

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Alain Benitez, MD, MSTR; Phone Number: 215-590-1000; Email: BenitezA@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Alain Benitez, MD, MSTR; Phone Number: 215-590-1000; Email: BenitezA@chop.edu
      • Contact: Binghong Xu, MD, MPH; Email: xub3@chop.edu
      • Principal Investigator: Alain Benitez, MD, MSTR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants meet the eligibility criteria listed.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IBS Cohort; Participants ages 8 to 18 years old who meet Rome IV diagnostic criteria for IBS	Diagnostic test: 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.
Control Cohort; Participants ageds 8-18 years old who don't have IBS	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately one year.

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Alain Benitez, MD, MSTR, Children's Hospital of Philadelphia, University of Pennsylvania

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Diet; Motility; Wireless Patch System
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: 22-020433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No