Study of Diet, Gut Movement, and Symptoms in Children and Teens with Irritable Bowel Syndrome IBS
Led by Children's Hospital of Philadelphia · Updated on 2025-12-15
90
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
A
Alain Benitez, MD, MSTR
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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
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
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
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...