Diet and Motility in IBS

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT07283341
Status
Recruiting
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Conditions

  • Irritable Bowel Syndrome (IBS)

Eligibility Criteria

Sex
ALL
Age
8 Years - 18 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Jul 31, 2023
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: IBS Cohort
    Participants ages 8 to 18 years old who meet Rome IV diagnostic criteria for IBS
  • Arm: Control Cohort
    Participants ageds 8-18 years old who don't have IBS

Primary Outcome Measure

Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS) [ Time Frame: Approximately one year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Alain Benitez, MD, MSTR
[email protected]
215-590-1000
Binghong Xu, MD, MPH
[email protected]
Alain Benitez, MD, MSTR (PRINCIPAL_INVESTIGATOR)

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