Liquid Diets for Crohn's Disease
(mRE-EEN Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Seattle Children's Hospital
Must not be taking: Corticosteroids, Immunomodulators, Azathioprine, Methotrexate
Disqualifiers: Surgery, Perianal disease, Biologicals, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
17111213Eligibility 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
+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.
+9 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Izaak Walton Killam Health CentreHalifax, Canada
Children's Hospital of PhiladelphiaPhiladelphia, PA
Seattle Children's HospitalSeattle, WA
Loading ...
Who Is Running the Clinical Trial?
Seattle Children's HospitalLead Sponsor
Children's Hospital of PhiladelphiaCollaborator
Dalhousie UniversityCollaborator
References
Crohn's disease: nutrition and nutritional therapy. [2019]Disordered nutrition is common in Crohn's disease and is multifactorial. Regular and systematic monitoring of at least a minimum set of nutrition data is an essential component of care of children and adults with Crohn's disease. However, even in children, monitoring of growth and development may be deficient. Multiple macro- and micronutrient deficiencies are common in Crohn's disease, especially in those with extensive small bowel deficiencies or after multiple surgical resections. Body composition analysis may show differences from simple starvation, and metabolic effects of inflammation are increasingly being recognized. Nutritional support is part of the management of all patients with Crohn's disease, but nutritional intervention with defined formula liquid diet is an effective specific anti-inflammatory therapy. Although meta-analysis of published trials suggest that steroids are more effective than defined formula liquid diets, objective evidence from whole gut lavage fluid analysis and from faecal excretion of radiolabelled leukocytes shows unequivocal benefit of elemental diet based on measuring parameters of tissue damage. Enteral feeding with liquid diets should be considered in patients with incomplete small bowel obstruction, severe painful perianal disease, failure of corticosteroids in active Crohn's disease, borderline intestinal failure and in children with active Crohn's disease or with growth failure.
Maintenance of Remission with Partial Enteral Nutrition Therapy in Pediatric Crohn's Disease: A Retrospective Study. [2019]Partial enteral nutrition (PEN) may be helpful for the maintenance of remission in pediatric Crohn's disease patients.
Exclusive whole protein enteral diet versus prednisolone in the treatment of acute Crohn's disease in children. [2022]Nineteen children with either newly diagnosed or relapsed Crohn's disease were enrolled in a randomized study in which the efficacy of enteral feeding with a whole protein-based formula was compared to high-dose corticosteroids in achieving clinical remission and normalization of laboratory measurements. Ten children were treated by enteral feeding (Nutrison Standard, Nutricia), and nine received corticosteroids. Both treatment regimens lasted 11 weeks. The activity of Crohn's disease was similar in both groups before the commencement of the treatment. Clinical symptoms and signs, as judged by the pediatric Crohn's disease activity index and measurements relating to inflammatory activity (erythrocyte sedimentation rate, C-reactive protein, blood leukocyte and platelet count, and serum immunoglobulins G and A) and to nutritional status (concentrations of serum albumin, prealbumin, hemoglobin) improved rapidly and significantly with as little as 2 weeks' treatment in both treatment groups. In both groups, there was one relapse within 8 weeks after discontinuation of treatment, and one patient in both groups was operated on during the treatment period. During the routine follow-up after the trial (0.3-2.5 years; mean, 1.3 years) five of the corticosteroid group experienced a clinical relapse, whereas only one from the enteral feeding group relapsed. No side effects of enteral feeding were seen. Enteral feeding with a whole protein-based formula proved to be as effective as high-dose corticosteroid in the treatment of the acute phase of Crohn's disease and may prove to be the treatment of choice in pediatric patients with acute Crohn's disease.
Improved growth and disease activity after intermittent administration of a defined formula diet in children with Crohn's disease. [2017]Growth failure is the most common extraintestinal manifestation of Crohn's disease in childhood, occurring in up to 50% to 88% of affected patients. Previous studies have shown malnutrition to be the most likely cause of the decrease in height and weight velocities in these children. The purpose of this study was to determine the effect of an intermittent defined formula diet on growth and disease activity in children with Crohn's disease and growth failure. Six Tanner stage I-II patients, mean age 13.6 years with height less than the 5th percentile or height velocity less than the 3rd percentile were enrolled in a 1-year prospective study. An isotonic, hydrolyzed whey, medium-chain triglyceride formula was given by nocturnal nasogastric infusion at a caloric equivalent of 50th percentile for age, as the exclusive nutrient source 1 out of 4 months during a 1-year period. A 2-week exclusion diet and a 2-week low-residue diet followed the defined formula diet before resuming the regular diet for 2 months. Patients served as their individual control based on observations of at least 1 year before the study. Height and weight velocity significantly increased. Prednisone intake significantly decreased, and significant improvement was seen in disease activity, albumin, and somatomedin C. The results indicate that an intermittent defined formula diet can improve growth failure and significantly decrease disease activity in children with Crohn's disease.
Review article: the dietary management of Crohn's disease. [2019]Enteral feeding has been shown to be as effective as primary therapy for Crohn's disease, but it requires high patient motivation, may be unpalatable and is expensive. However, in adolescents with growth failure and when corticosteroid therapy is contra-indicated or has failed, it may become the treatment of choice. Furthermore, dietary therapy allows circumvention of the adverse side-effects of repeated courses of steroids. A number of different hypotheses have been proposed to explain the effect of enteral feeds but none has reached universal acceptance. Prospective trials suggest that the exclusion of whole protein is not necessary. Comparison of feeds with differing composition suggests that a low fat content increases efficacy and various explanations have been offered. The reduction of colonic bacterial load may also be important. Because symptoms of Crohn's disease may be provoked by eating, there is a risk of falsely attributing symptoms to specific foodstuffs. However, in many individuals foods can be identified which affect disease activity, and their exclusion leads to prolongation of disease remission. Dietetic supervision during food testing is important to avoid detrimental effects on nutrient and micronutrient intake.
Blenderized enteral nutrition in pediatric short gut syndrome: Tolerance and clinical outcomes. [2023]Blenderized feeds consisting of whole food components are emerging as a preferred approach to enteral nutrition. However, there is limited evidence-based guidance for this strategy in short bowel syndrome (SBS). We aimed to explore the tolerance and clinical outcome of blenderized feeds in patients with SBS.
Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. [2019]Exclusive enteral nutrition (EEN) is recommended for children with mild to moderate Crohn's disease (CD), but implementation is challenging. We compared EEN with the CD exclusion diet (CDED), a whole-food diet coupled with partial enteral nutrition (PEN), designed to reduce exposure to dietary components that have adverse effects on the microbiome and intestinal barrier.
Caregivers' Perceptions of Real-Food Containing Tube Feeding: A Canadian Survey. [2021]Caregivers of children requiring tube feeding show growing interest in real-food containing formula, including home-blenderized tube feeding (HBTF) and commercial real-food containing formulas (CRFCF). This study aimed to understand caregivers' perceptions of both. Caregivers using real-food containing tube feeding were recruited through the Feeding Tube Awareness Foundation Facebook group. A 13-question online survey asked about use of HBTF and CRFCF, beliefs about their choices, and what resources guided formula use. Forty-one completed the survey, with mean child age of 7 years. Overall, 54% (n = 22) used HBTF formulas, 34% (n = 14) CRFCF, and 12% (n = 5) used both. For 70% (n = 29), presence of whole foods, nutritional completeness, and natural ingredients were most important. Challenges with CRFCF use included lack of variety (n = 10, 53%) and cost (n = 9, 47%). HBTF challenges were difficulty preparing away from home (n = 19, 70%) and need for special blenders (n = 15, 56%). Participants believed CRFCF are convenient (n = 35, 85%) and nutritionally consistent (n = 25, 61%), but do not contain enough real-food ingredients (n = 26, 63%). Facebook or other social media was the most valued resource guiding formula use (n = 25, 61%). Caregivers desire formulas that are nutritionally complete and made of whole foods. CRFCF offers convenience and consistency, yet caregivers prefer more real-food ingredients.
Crohn's disease exclusion diet in children with Crohn's disease: a case series. [2021]Exclusive enteral nutrition (EEN) represents an established, evidence-based dietary therapy used in Crohn's disease (CD); although successful, EEN is extremely restrictive with limited acceptability and prolonged use. The Crohn's disease exclusion diet (CDED) is a new, sustainable and patient-friendly dietary therapy used for the management of pediatric CD. CDED is designed to reduce exposure to dietary components hypothesized to negatively affect the microbiome, intestinal barrier and immunity. By focusing on five clinical cases, this article illustrates the benefits of using CDED as mono- or co-therapy with partial enteral nutrition in children with mild to moderate CD. CDED combined with partial enteral nutrition is a safe and effective therapeutic option for both induction and maintenance therapy in children with mild to moderate CD. It ensures sustained remission and can induce mucosal healing in children with mild to moderate Crohn's disease.
A systematic review examining the impact of blended diets on the gastrointestinal symptoms of people who are enterally fed. [2023]Adults and children who are enterally tube-fed can experience adverse gastrointestinal symptoms (GIS). Observational data suggests that blended diets (BD) could mitigate such symptoms, with potential to improve quality of life and clinical outcomes. We present a novel systematic review examining the impact of BD, compared to commercial feeds, on GIS of adults and children who are tube-fed.
Supplementary enteral nutrition maintains remission in paediatric Crohn's disease. [2022]Liquid diets given enterally combined with "bowel rest' are efficacious in the treatment of active Crohn's disease, but rapid recrudescence of gastrointestinal symptoms after resumption of a normal diet is common.
Polymeric nutrition as the primary therapy in children with small bowel Crohn's disease. [2019]Recent studies in adults have shown that polymeric (whole protein) diets are as effective as semi-elemental and elemental formulae for the induction of remission in small bowel Crohn's disease. Whole protein diets are more palatable and cheaper. There have been no studies confirming efficacy in children.
Does polymeric formula improve adherence to liquid diet therapy in children with active Crohn's disease? [2018]Active Crohn's disease can be treated using liquid diet therapy (LDT), but non-adherence may limit success, necessitating corticosteroid therapy. Whole-protein polymeric formula (PF) seems to be much more palatable than amino acid-based elemental formula (EF) and thus may significantly improve adherence to LDT.