Diet and Motility in IBS

Children's Hospital of Philadelphia (CHOP)

Status: Enrolling

Conditions: Irritable Bowel Syndrome (IBS)

Treatments: Diagnostic Test: Wireless Patch System

Study type: Observational

Funder types: Other

Identifiers

NCT07283341

22-020433

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Cases:

1. Males and females age 8 - 18 years
2. Diagnosis of irritable bowel syndrome (IBS).
3. Parental/guardian permission (informed consent) and child assent

Controls:

1. Males and Females age 8-18 years
2. No diagnosis of abdominal pain disorder
3. Parental/guardian permission (informed consent) and child assent

Exclusion criteria

Cases:

1. Allergy to adhesives
2. Inability to cooperate with study design
3. Antibiotic intake in the past 4 weeks
4. Inflammatory gastrointestinal disorder diagnosis

Controls:

1. Allergy to adhesives
2. Inability to cooperate with study design
3. Antibiotic intake in the past 4 weeks
4. Inflammatory gastrointestinal disorder diagnosis

Trial design

90 participants in 2 patient groups

IBS Cohort

Description:

Participants ages 8 to 18 years old who meet Rome IV diagnostic criteria for IBS

Treatment:

Diagnostic Test: Wireless Patch System

Control Cohort

Description:

Participants ageds 8-18 years old who don't have IBS

Treatment:

Diagnostic Test: Wireless Patch System