Diet and Motility in IBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-31

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome (IBS)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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IBS Cohort

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

Wireless Patch System

Intervention Type 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.

Control Cohort

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

Wireless Patch System

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes