Recruiting

NCT Number: NCT07283341

Diet and Motility in 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.

Recruiting

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Alain Benitez, MD, MSTR

CONTACT

[email protected]

215-590-1000

Alain Benitez, MD, MSTR

PRINCIPAL_INVESTIGATOR

Binghong Xu, MD, MPH

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alain Benitez, MD, MSTR

CONTACT

[email protected]

215-590-1000

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

The Role of Diet and Gastrointestinal Motility in Irritable Bowel Syndrome (IBS)

Acronym: IBS

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Dec 15, 2025
Registry last updated: Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting