Diet and Motility in IBS

NCT07283341 | Recruiting

• 1 other identifier: 22-020433
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome; Diet; Motility; Wireless Patch System

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

IBS Cohort

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

Diagnostic Test: Wireless Patch System

Control Cohort

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

Diagnostic Test: Wireless Patch System

Interventions

Wireless Patch System DIAGNOSTIC_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.

Control Cohort; IBS Cohort

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants meet the eligibility criteria listed.

You may qualify if:

• 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

You may not qualify if:

• Cases:
• Allergy to adhesives
• Inability to cooperate with study design
• Antibiotic intake in the past 4 weeks
• Inflammatory gastrointestinal disorder diagnosis
• Controls:
• Allergy to adhesives
• Inability to cooperate with study design
• Antibiotic intake in the past 4 weeks
• Inflammatory gastrointestinal disorder diagnosis

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33063188 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Stool

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Alain Benitez, MD, MSTR

  Children's Hospital of Philadelphia, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain Benitez, MD, MSTR

CONTACT

215-590-1000; BenitezA@chop.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: July 31, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)