Purpose of this Study
Children with IBS will eat a food called fructans to see if it makes their symptoms worse. If it does, they will be placed into one of three groups. One group will get a fake treatment called a placebo. The other two groups will get a fiber called psyllium in different amounts based on their age. They will take this for two weeks. During this time, they will check their poop and write down how they feel. The whole study may last up to three months.
Who Can Participate?
Eligibility
To join the study, children must be between 12 and 17 years old and have irritable bowel syndrome based on special rules called Rome IV.
Children cannot join if they have had bowel surgery, other stomach diseases like ulcerative colitis, or serious health problems like diabetes. They also cannot join if their height or weight is far from normal for their age. Children with other long-term illnesses that affect the stomach, like cystic fibrosis or kidney disease, cannot join either.
Children who took antibiotics or probiotics in the last 3 months cannot join because these change the stomach bacteria. Children who are pregnant or have conditions like autism, major depression, or bipolar disorder cannot join because these make it hard to report symptoms. Children taking certain medicines, like diabetes or heart medicines, also cannot join.
Age Range
12-17
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The study wants to find out if psyllium can help children who have stomach pain because of irritable bowel syndrome and are sensitive to fructans.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Assessing Psyllium given with Meals for Fructan Sensitivity in Children with Irritable Bowel Syndrome
Principal Investigator
Bruno
Chumpitazi
Protocol Number
PRO00114630
NCT ID
NCT06639984
Phase
III
Enrollment Status
Open to Enrollment