60 Participants Needed

Liquid Diets for Crohn's Disease

(mRE-EEN Trial)

Recruiting at 2 trial locations
ME
DG
Overseen ByDanny Gagucas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot have recently used corticosteroids, adjusted immunomodulators, or started certain medications like azathioprine or methotrexate close to the study's end. It's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment for Crohn's disease?

Research shows that liquid diets, like defined formula diets, can be effective in reducing inflammation and improving growth in children with Crohn's disease. These diets have been found to be as effective as corticosteroids in managing symptoms and may help maintain remission, especially in pediatric patients.12345

Is a liquid diet safe for people with Crohn's disease?

Research suggests that liquid diets, including those with whole-food ingredients, are generally safe for people with Crohn's disease and other conditions. They can help manage symptoms and improve quality of life, although they may require special preparation and equipment.678910

How is the liquid diet treatment for Crohn's disease different from other treatments?

This treatment uses a whole-food based smoothie or formula as a liquid diet, which can be more palatable and improve adherence compared to other liquid diets. It is designed to maintain remission and reduce inflammation in Crohn's disease, offering an alternative to steroid treatments.17111213

What is the purpose of this trial?

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. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.

Research Team

DL

Dale Lee, MD, MSCE

Principal Investigator

Seattle Children's Hospital, University of Washington

Eligibility Criteria

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.

Inclusion Criteria

I am between 8 and 21 years old.
Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin
Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent
See 2 more

Exclusion Criteria

I have not taken corticosteroids in the last 4 weeks.
I have used biological medication before.
I was hospitalized because my Crohn's disease got very severe.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either conventional formula or whole-food blended smoothie EEN for 8 weeks

8 weeks
3 visits (in-person) at week 2, week 4, and week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Formula
  • Whole-food based smoothie
Trial Overview 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.
Participant Groups
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.

Formula is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Infant Formula for:
  • Nutritional support for infants
🇺🇸
Approved in United States as Baby Formula for:
  • Nutritional support for infants
  • Supplementation for breastfeeding
🇨🇦
Approved in Canada as Infant Formula for:
  • Nutritional support for infants
  • Supplementation for breastfeeding in well-baby units

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials
319
Recruited
5,232,000+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

Dalhousie University

Collaborator

Trials
177
Recruited
402,000+

Findings from Research

Regular monitoring of nutrition is crucial for managing Crohn's disease, as many patients experience macro- and micronutrient deficiencies, particularly after surgeries or with extensive small bowel involvement.
Defined formula liquid diets are an effective anti-inflammatory therapy for Crohn's disease, showing benefits in reducing tissue damage, and should be considered in various clinical scenarios, including severe disease and growth failure in children.
Crohn's disease: nutrition and nutritional therapy.Ferguson, A., Glen, M., Ghosh, S.[2019]
Partial enteral nutrition (PEN) was found to be partially effective in maintaining remission in pediatric Crohn's disease patients, with a median remission length of 6 months after transitioning from exclusive enteral nutrition (EEN).
While PEN helped increase the mean body mass index (BMI) from 18.1 to 18.8 and reduced the weighted Pediatric Crohn Disease Activity Index (wPCDAI) from 30 to 7.5, most patients still needed additional medications to maintain remission after starting PEN.
Maintenance of Remission with Partial Enteral Nutrition Therapy in Pediatric Crohn's Disease: A Retrospective Study.Schulman, JM., Pritzker, L., Shaoul, R.[2019]
Enteral feeding with a whole protein-based formula was found to be as effective as high-dose corticosteroids in achieving clinical remission in children with Crohn's disease, based on a study of 19 participants over 11 weeks.
The enteral feeding group had a lower relapse rate during follow-up (1 relapse) compared to the corticosteroid group (5 relapses), and no side effects were reported from the enteral feeding, suggesting it may be a safer long-term treatment option.
Exclusive whole protein enteral diet versus prednisolone in the treatment of acute Crohn's disease in children.Ruuska, T., Savilahti, E., Mäki, M., et al.[2022]

References

Crohn's disease: nutrition and nutritional therapy. [2019]
Maintenance of Remission with Partial Enteral Nutrition Therapy in Pediatric Crohn's Disease: A Retrospective Study. [2019]
Exclusive whole protein enteral diet versus prednisolone in the treatment of acute Crohn's disease in children. [2022]
Improved growth and disease activity after intermittent administration of a defined formula diet in children with Crohn's disease. [2017]
Review article: the dietary management of Crohn's disease. [2019]
Blenderized enteral nutrition in pediatric short gut syndrome: Tolerance and clinical outcomes. [2023]
Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. [2019]
Caregivers' Perceptions of Real-Food Containing Tube Feeding: A Canadian Survey. [2021]
Crohn's disease exclusion diet in children with Crohn's disease: a case series. [2021]
A systematic review examining the impact of blended diets on the gastrointestinal symptoms of people who are enterally fed. [2023]
Supplementary enteral nutrition maintains remission in paediatric Crohn's disease. [2022]
Polymeric nutrition as the primary therapy in children with small bowel Crohn's disease. [2019]
Does polymeric formula improve adherence to liquid diet therapy in children with active Crohn's disease? [2018]
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