Psyllium in IBS

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