NCT07224113Recruiting
Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
This study explores whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) eat fewer ultra-processed foods (UPFs). UPFs include packaged snacks, sugary drinks, and fast food-items that are high in added sugars, fats, and artificial ingredients. Participants will complete online food recalls to measure what they eat and will then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Researchers will compare changes in UPF intake between the two groups after several weeks and ask families how useful and acceptable they found the materials. The goal is to identify an effective, practical way to support healthier eating habits and long-term gut health in pediatric IBD.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 31 Oct 2025
- Start date
- 10 Nov 2025
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Connecticut Children's Medical Center
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT07224113
What you commit to
- Study type: Observational
- Planned participants: 120
- From 10 Nov 2025 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving any nutrition through feeding tubes (including nasogastric \[NG\], nasojejunal \[NJ\], gastrostomy \[G\], or gastrojejunostomy \[GJ\] tubes)
Other illness
- 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.
- History of bowel surgery within 3 months of study start affecting ability to sustain normal enteral intake
Other
- Non-English-speaking participants (as translation and short-form consent processes will not be used for this study)
Who the study is looking for
- 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
Age in the registry: 10 years to 21 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.