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Nutritional Therapy

Liquid Diets for Crohn's Disease (mRE-EEN Trial)

N/A
Recruiting
Led By Dale Lee, MD, MSCE
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10
Age 8 - 21 years old
Must not have
History of surgery for Crohn's disease
Azathioprine use 4 weeks prior to study final visit (week 8)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial will compare how well two types of liquid diets work for children with newly diagnosed Crohn's disease. One group will drink a commercial formula, while the other will make a smoothie at home

Who is the study for?
This trial is for children and young adults aged 8-21 who have been diagnosed with Crohn's disease within the last two years. They must show active symptoms, as indicated by a specific activity index score (PCDAI ≥10) and elevated inflammation markers. Participants or their guardians must be able to give informed consent.
What is being tested?
The study compares traditional formula-based Exclusive Enteral Nutrition (EEN) with a whole-food based smoothie EEN in treating pediatric Crohn's disease. It will assess which method is more tolerable, effective, and how they affect life quality and gut bacteria over an 8-week period.
What are the potential side effects?
Potential side effects may include gastrointestinal discomfort such as nausea or bloating due to dietary changes. Since this involves nutrition rather than medication, severe side effects are less likely compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Crohn's disease is currently active.
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I am between 8 and 21 years old.
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I was diagnosed with Crohn's disease in the last 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery for Crohn's disease.
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I have not taken Azathioprine in the 4 weeks before my final study visit.
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I have tried dietary therapy for Crohn's disease before.
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My Crohn's disease includes perianal complications.
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I have used biological medication before.
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I have taken antibiotics for Crohn's disease before.
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I was hospitalized because my Crohn's disease got very severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tolerance- Ability to remain on prescribed nutritional therapy
Secondary study objectives
Fecal Calprotectin reduction from baseline
Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SmoothieExperimental Treatment1 Intervention
In the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home.
Group II: FormulaActive Control1 Intervention
In the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians.

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,020 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
729 Previous Clinical Trials
8,470,251 Total Patients Enrolled
Dalhousie UniversityOTHER
173 Previous Clinical Trials
401,794 Total Patients Enrolled
~40 spots leftby Apr 2026
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