Reducing ultra-processed foods in children and teens with IBD
Official title: Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
Run by Connecticut Children's Medical Center · NCT07224113 · Data updated 2026-11-12
This project will test whether short nutrition handouts or handouts plus a brief video can help children and teens with IBD eat fewer ultra-processed foods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 10 Years to 21 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Status | Recruiting |
| Started | November 10, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT07224113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents age 10–21 with a confirmed IBD diagnosis for at least 3 months who are in clinical remission, followed by a gastroenterologist at Connecticut Children's, receiving infusions at the CCMC Infusion Center, and able to eat orally without major dietary restrictions.
✕Probably not a fit
Patients on medically prescribed or restrictive diets, receiving nutrition via feeding tubes, or with recent bowel surgery are excluded and likely would not benefit from these general education materials.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with pediatric IBD will complete online 24-hour food recalls to measure baseline ultra-processed food (UPF) intake and then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Intake will be re-measured after several weeks to compare changes in UPF consumption between the two groups. Families will also complete questionnaires about how useful and acceptable they found the materials. The study focuses on patients followed at Connecticut Children's who are in clinical remission and receiving routine infusions.
Why it matters
Potential benefit: If successful, this simple education could help young people with IBD reduce UPF intake and support healthier long-term gut outcomes.
How similar studies have gone: Some general-population and adult studies show education can lower UPF intake, but few trials have directly tested brief educational interventions specifically in pediatric IBD.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of IBD (Crohn's disease, Ulcerative Colitis, IBD-U) for at least 3 months * Age 10 through \< 22 years at the time of enrollment (i.e., up to the day before the 22nd birthday) * Followed by a gastroenterologist at Connecticut Children's * IBD in clinical remission based on calculated PUCAI score \<10 or PCDAI score of \<10 * Receiving medical infusions at CCMC Infusion Center as part of IBD treatment * Participants must be on full oral intake and not have major dietary restrictions or require oral nutrition supplements Exclusion Criteria: * Following a medically prescribed or restrictive diet such as Crohn's Disease Exclusion Diet (CDED), ketogenic diet, Specific Carbohydrate Diet (SCD), low FODMAP diet, gluten-free diet, paleo, or Whole30. * Receiving any nutrition through feeding tubes (including nasogastric \[NG\], nasojejunal \[NJ\], gastrostomy \[G\], or gastrojejunostomy \[GJ\] tubes) * History of bowel surgery within 3 months of study start affecting ability to sustain normal enteral intake * Non-English-speaking participants (as translation and short-form consent processes will not be used for this study)
Where it's running
-
Connecticut Children's Medical Center
Hartford, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Giselle Davila-Bernardy, MD — Connecticut Children's Medical Center
- Study coordinator: Giselle M Davila Bernardy, MD
- Email: gdavilabernardy@connecticutchildrens.org
- Phone: 8605459560
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SMART-IBD app for teens with inflammatory bowel disease
This will test whether the SMART-IBD smartphone app helps adolescents ages 13–17 with IBD take their medicines and manage symptoms better than completing daily diaries alone.
-
Wearable data to spot IBD flareups in people with ulcerative colitis or Crohn's disease
This study tests whether heart‑rate variability from participants’ own wearables can help predict IBD flares.
-
Switching to guselkumab for adults with active IBD after ustekinumab
We will try guselkumab (Tremfya) in adults with active IBD whose symptoms didn't improve enough on ustekinumab.
-
TIDHI Healing Circuits mental health program for people with IBD
This study tests whether Healing Circuits™ delivered by a social worker or via a self-guided online program helps adults with IBD who have moderate anxiety or depression.
-
Optimizing Infliximab Treatment for Inflammatory Bowel Disease
This study is testing a new way to give infliximab to adults with moderate-to-severe inflammatory bowel disease who haven't improved with steroids, to see if personalized dosing can help them feel better.
-
Familial IBD Early Risk
This study tests whether clinical, environmental, and immune factors in first-degree relatives of people with Crohn’s disease or ulcerative colitis can predict who will develop IBD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.