Psyllium in Pediatric IBS
Launched by DR BRUNO CHUMPITAZI, M.D. · Oct 10, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a type of fiber called psyllium can help children with irritable bowel syndrome (IBS) feel better when they eat foods containing fructans, which are a type of sugar. The researchers want to see how psyllium affects the bacteria in the gut and if it can reduce the stomach issues that some kids experience after eating fructans. Participants will first follow a special diet for six days to see if fructans make their IBS symptoms worse. If they do, they can join the second part of the study, which involves two weeks of testing where they will eat a specific diet with fructans along with either psyllium or glucose.
To be eligible for this trial, children aged 12 to 17 must meet certain criteria for IBS. They should not have had previous bowel surgery or serious gastrointestinal disorders, nor should they have other chronic health issues. Additionally, they must not have taken antibiotics or probiotics in the last three months. During the trial, participants will keep track of their pain and bowel movements, provide stool samples, and undergo some tests to measure gut acid levels. This study is currently looking for participants, and it's a chance for kids with IBS to potentially find relief from their symptoms.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Children between the ages of 12-17 years meeting pediatric Rome IV criteria for IBS
- Exclusion Criteria:
- • Children who have had previous bowel surgery, have documented GI disorders (e.g., ulcerative colitis), or a serious chronic medical condition (e.g., diabetes)
- • weight and/or height are \> or \< 2 SD for age
- • have chronic conditions with GI symptoms (e.g., cystic fibrosis)
- • have been on antibiotics or probiotics within 3 months (because of potential alterations to the GI microbiome0
- • girls who are pregnant (tested with urine beta-human chorionic gonadotropin at the initial visit)
About Dr Bruno Chumpitazi, M.D.
Dr. Bruno Chumpitazi, M.D., is a distinguished clinical trial sponsor with a robust background in pediatric medicine and clinical research. With a commitment to advancing healthcare through innovative studies, Dr. Chumpitazi leads initiatives focused on improving treatment outcomes for children with various medical conditions. His expertise in designing and overseeing clinical trials ensures rigorous adherence to ethical standards and regulatory compliance, while fostering collaboration among multidisciplinary teams. Dr. Chumpitazi's dedication to patient-centered research drives his efforts to translate scientific findings into effective therapies, ultimately enhancing the quality of care for young patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Patients applied
Trial Officials
Bruno Chumpitazi, MD, MPH
Principal Investigator
Duke University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported