Diet and Motility in IBS
ConditionIrritable Bowel Syndrome (IBS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-18
SponsorChildren's Hospital of Philadelphia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females age 8 - 18 years
Diagnosis of irritable bowel syndrome (IBS).
Parental/guardian permission (informed consent) and child assent
Males and Females age 8-18 years
Disqualifiers
Allergy to adhesives
Inability to cooperate with study design
Antibiotic intake in the past 4 weeks
Inflammatory gastrointestinal disorder diagnosis
Trial population
Participants meet the eligibility criteria listed.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Wireless Patch System
Diagnostic testThe 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: IBS Cohort1 intervention
Group B: Control Cohort1 intervention
Trial outcomes
Primary outcomes
1
Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS)
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.
Time frame
Approximately one year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov