Actively Recruiting

Age: 8Years - 18Years
All Genders
Healthy Volunteers
ID07283341

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

Led by Children's Hospital of Philadelphia · Updated on 2025-12-15

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating factors that influence symptoms in children aged 8 to 18 years with irritable bowel syndrome (IBS). This observational study aims to understand how diet relates to IBS symptoms, identify motility patterns using a wearable patch, and explore the types of bacteria and chemicals in the gut and urine linked to IBS. The goal is to improve diet treatments and possibly develop personalized plans to help children feel better. Participants will wear a wireless patch on their abdomen that records gut activity and use an iPhone app to log symptoms and meals. The study has two groups: children diagnosed with IBS and children without abdominal pain disorders as controls. Some participants undergoing dietary changes will complete study procedures before and after their diet intervention. During the study, children will wear the patch, answer questionnaires, provide stool and urine samples, and recall their diet over 24 hours. Researchers will measure gut myoelectric activity over approximately one year. Participation includes monitoring diet, symptoms, and motility patterns to better understand IBS, with safety and cooperation closely observed throughout the study period.

CONDITIONS

Brief Title

Diet and Motility in IBS

Who Can Participate

Age: 8Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 8 to 18 years
  • Diagnosis of irritable bowel syndrome (IBS) for the IBS group
  • No diagnosis of abdominal pain disorder for the control group
  • Parental or guardian permission and child assent
Not Eligible

You will not qualify if you...

  • Allergy to adhesives
  • Inability to cooperate with study procedures
  • Antibiotic use in the past 4 weeks
  • Diagnosis of inflammatory gastrointestinal disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 year

Participants will have a Wireless Patch System placed on the abdominal skin to record gut myoelectric activity. They will also use an iPhone app to log symptoms and meals.

Periodic assessments during the year

Surveillance

Duration - Varies based on dietary intervention timing

Participants undergoing a clinically indicated dietary intervention will complete study procedures before and after the intervention to observe changes in gastrointestinal motility.

Assessments before and after dietary intervention

Trial Site Locations

Total: 1 location

1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

A

Alain Benitez, MD, MSTR

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic and Disease Correlations.

Lindsay Axelrod, Steve Axelrod, Anand Navalgund...

https://pubmed.ncbi.nlm.nih.gov/33063188