| NCT ID | NCT07283341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Irritable Bowel Syndrome (IBS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-07-31 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2023-07-31 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Alain Benitez, MD, MSTR
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia, University of Pennsylvania
Frequently Asked Questions
Who can join the NCT07283341 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Irritable Bowel Syndrome (IBS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07283341 currently recruiting?
Yes, NCT07283341 is actively recruiting participants. Contact the research team at BenitezA@chop.edu for enrollment information.
Where is the NCT07283341 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07283341 clinical trial?
NCT07283341 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Alain Benitez, MD, MSTR at Children's Hospital of Philadelphia, University of Pennsylvania. The trial plans to enroll 90 participants.