Diet and stress management combined with medication for inflammatory bowel disease

Plain-English translation of NCT07168499 on ClinicalTrials.gov ↗ ·

What is this trial?

This trial is testing whether combining lifestyle changes — specifically nutrition support and stress management techniques — with advanced IBD medications can help people with Crohn's disease or ulcerative colitis achieve and maintain remission better than medication alone. Researchers will compare four different groups to see if adding these lifestyle supports early on makes a real difference in how well your disease is controlled.

IBD is a chronic disease where people experience repeated flare-ups, and doctors want to know if combining the medication with personalized diet and stress counseling from day one might help people stay in remission longer and feel better overall.

Do you qualify?

You likely qualify if…

you are at least 18 years old
you have been diagnosed with Crohn's disease, ulcerative colitis, or IBD-unspecified
you have active IBD confirmed in the last 6 months by imaging, colonoscopy, or blood tests
you are starting a new advanced IBD medication within 2 weeks of enrolling
you have moderate to active disease symptoms at the time you enroll

You likely don't qualify if…

you have a known eating disorder
you are already receiving diet counseling or stress management therapy for your IBD
you have untreated severe mental health conditions, including any history of suicidal thoughts
you are pregnant, breastfeeding, or planning to become pregnant during the study
you have an active untreated infection like C. difficile

What participation looks like

You'll be randomly assigned to one of four groups. Group A receives both diet counseling and stress management visits within the first month and again a few weeks later. Group B receives diet counseling only (with stress management offered later). Group C receives stress management only (with diet counseling offered later). Group D receives both services after three months. All participants will complete questionnaires and have the option to provide blood and stool samples at certain visits to help researchers understand how the treatments are working.

Diet and stress management combined with medication for inflammatory bowel disease

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)