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New treatment option for Crohn Disease
Official title Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
ClinicalTrials.gov ID: NCT06216899
What this study is testing
- What it's testing
- This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 21
You may be able to join if
- Age 8 -21 years old.
- Diagnosis of Crohn's disease within 24 months
- Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin
- Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.
- Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent.
You likely can't join if
- History of surgery for Crohn's disease.
- Perianal disease as part of Crohn's disease phenotype.
- Recent use of:
- corticosteroids (within 4 weeks),
- dose adjustment of immunomodulator (within 8 week)
- azathioprine 4 weeks prior to study final visit (week 8)
See the full eligibility criteria
- Age 8 -21 years old.
- Diagnosis of Crohn's disease within 24 months
- Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin
- Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.
- Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent.
- History of surgery for Crohn's disease.
- Perianal disease as part of Crohn's disease phenotype.
- Recent use of:
- corticosteroids (within 4 weeks),
- dose adjustment of immunomodulator (within 8 week)
- azathioprine 4 weeks prior to study final visit (week 8)
- start or adjust methotrexate 3 weeks prior to final study visit.
- Prior use of biological medication
- Prior treatment with EEN or other dietary therapy for Crohn's disease.
- Prior treatment with antibiotics for Crohn's disease.
- Known allergies to any of the food components in the smoothie.
- Admission to hospital due to severity of Crohn's disease and associated symptoms.
- Unwillingness to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Halifax, Nova Scotia, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; Seattle, Washington, United States; Halifax, Nova Scotia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.