Diet and Motility in IBS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wireless Patch System.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome (IBS). Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Diet and Gastrointestinal Motility in Irritable Bowel Syndrome (IBS)
Overview
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.
Interventions
- Diagnostic test Wireless Patch System
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 outcome measures
- Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS) [Time frame: Approximately one year.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Children's Hospital of Philadelphia — Philadelphia
Publications
- 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
Identifiers
NCT: NCT07283341 · 22-020433