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Diet and Motility in IBS

The Role of Diet and Gastrointestinal Motility in Irritable Bowel Syndrome (IBS)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07283341
Acronym
IBS
Enrollment
90
Registered
2025-12-15
Start date
2023-07-31
Completion date
2027-06-30
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome, Diet, Motility, Wireless Patch System

Brief summary

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_TESTWireless 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.

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gut myoelectric activity in children with IBS and controls using the non-invasive wireless patch system (WPS)Approximately one year.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.

Countries

United States

Contacts

Primary ContactAlain Benitez, MD, MSTR
BenitezA@chop.edu215-590-1000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026