Crohn DiseaseRE-EENNCT03508193
Reverse Engineering of Exclusive Enteral Nutrition
A study testing Nutritional therapy in people with Crohn Disease, run by Dale Lee at 1 site in United States.
Trial summary
Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease. Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Nutritional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2017to 5 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8 -21 years old
- Diagnosis of Crohn's disease within 4 weeks of study entry
- 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
Who cannot join
- History of surgery for Crohn's disease
- Perianal disease as part of Crohn's disease phenotype
- Prior treatment with EEN or the specific carbohydrate for Crohn's disease
- Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha agent, azathioprine, methotrexate, etc.)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease
Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease.
Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls.
Read more
The specific aims of this proposal are:
- To develop a whole-food based smoothie, based on principles of the specific carbohydrate diet, that is comparable in macronutrients and micronutrients to formulas used for exclusive enteral nutritional (EEN) therapy in Crohn's disease.
- To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease.
- To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.
Read the detailed description
This will be an open label, pilot study over 4 weeks in children with newly diagnosed Crohn's disease treated with a smoothie designed to emulate formulas used for exclusive enteral nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to create the smoothies will be given to each participant/family. The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie recipes will involve whole foods that can be blenderized to liquid consistency. Similar to the formulas used for EEN, the smoothies will provide calories, protein, fat, and carbohydrates in a distribution to support growth and development.
- Conditions
- Crohn Disease
- Being tested
- Nutritional therapy
- Keywords
- Exclusive Enteral Nutrition, Nutrition, Diet, Inflammatory Bowel Disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional therapyOther
Whole-foods based smoothie designed to emulate formulas used in EEN
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Whole-foods based smoothie as nutritional therapy Receives: Other: Nutritional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal calprotectin <250 micrograms/gram
surrogate marker of intestinal inflammation
Measured: 4 weeks
Secondary outcomes (1)
Quality of life as measured by IMPACT III Questionnaire
validated quality of life measure for pediatric inflammatory bowel disease
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start4 Nov 2017
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dale Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dale Lee, Seattle Children's Hospital
- Investigators
- Dale Y Lee, MD, Principal investigator, Seattle Children's Hospital and The University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508193
- Sponsor's protocol ID
- STUDY00000619
- Acronym
- RE-EEN
- Status last verified
- Nov 2022
- First submitted
- 16 Apr 2018
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not Discussed
Publications
Johnson T, Macdonald S, Hill SM, Thomas A, Murphy MS. Treatment of active Crohn's disease in children using partial enteral nutrition with liquid formula: a randomised controlled trial. Gut. 2006 Mar;55(3):356-61. doi: 10.1136/gut.2004.062554. Epub 2005 Sep 14.
PubMed 16162683Lee D, Baldassano RN, Otley AR, Albenberg L, Griffiths AM, Compher C, Chen EZ, Li H, Gilroy E, Nessel L, Grant A, Chehoud C, Bushman FD, Wu GD, Lewis JD. Comparative Effectiveness of Nutritional and Biological Therapy in North American Children with Active Crohn's Disease. Inflamm Bowel Dis. 2015 Aug;21(8):1786-93. doi: 10.1097/MIB.0000000000000426.
PubMed 25970545Lee D, Braly K, Nuding M, Braly I, Hopp C, Twible H, Pope C, Hayden HS, Hoffman L, Zheng H, Wahbeh G, Suskind DL. Reverse-engineered exclusive enteral nutrition in pediatric Crohn's disease: A pilot trial. J Pediatr Gastroenterol Nutr. 2024 May;78(5):1135-1142. doi: 10.1002/jpn3.12196. Epub 2024 Apr 1.
PubMed 38558411
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease
- ClinicalTrials.gov ID
- NCT03508193
- Acronym / sponsor ID
- RE-EEN / STUDY00000619
- Conditions
- Crohn Disease
- Keywords
- Exclusive Enteral Nutrition, Nutrition, Diet, Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dale LeeUniversity, hospital or other
- Study start
- 4 Nov 2017 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease.
Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls.
The specific aims of this proposal are:
- To develop a whole-food based smoothie, based on principles of the specific carbohydrate diet, that is comparable in macronutrients and micronutrients to formulas used for exclusive enteral nutritional (EEN) therapy in Crohn's disease.
- To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease.
- To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.
Detailed description
This will be an open label, pilot study over 4 weeks in children with newly diagnosed Crohn's disease treated with a smoothie designed to emulate formulas used for exclusive enteral nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to create the smoothies will be given to each participant/family. The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie recipes will involve whole foods that can be blenderized to liquid consistency. Similar to the formulas used for EEN, the smoothies will provide calories, protein, fat, and carbohydrates in a distribution to support growth and development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Nutritional therapyWhole-foods based smoothie as nutritional therapy |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 8 -21 years old
- Diagnosis of Crohn's disease within 4 weeks of study entry
- 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
Key exclusion criteria (8 listed)
- History of surgery for Crohn's disease
- Perianal disease as part of Crohn's disease phenotype
- Prior treatment with EEN or the specific carbohydrate for Crohn's disease
- Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha agent, azathioprine, methotrexate, etc.)
- Prior treatment with antibiotics for Crohn's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional therapyWhole-foods based smoothie designed to emulate formulas used in EEN | Other | Intervention |
Primary outcome
Fecal calprotectin <250 micrograms/gram
Time frame: 4 weeks
surrogate marker of intestinal inflammation
1 secondary outcome
Quality of life as measured by IMPACT III Questionnaire
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 16162683Johnson T, Macdonald S, Hill SM, Thomas A, Murphy MS. Treatment of active Crohn's disease in children using partial enteral nutrition with liquid formula: a randomised controlled trial. Gut. 2006 Mar;55(3):356-61. doi: 10.1136/gut.2004.062554. Epub 2005 Sep 14.
- Background: PubMed 25970545Lee D, Baldassano RN, Otley AR, Albenberg L, Griffiths AM, Compher C, Chen EZ, Li H, Gilroy E, Nessel L, Grant A, Chehoud C, Bushman FD, Wu GD, Lewis JD. Comparative Effectiveness of Nutritional and Biological Therapy in North American Children with Active Crohn's Disease. Inflamm Bowel Dis. 2015 Aug;21(8):1786-93. doi: 10.1097/MIB.0000000000000426.
- Derived from this study: PubMed 38558411Lee D, Braly K, Nuding M, Braly I, Hopp C, Twible H, Pope C, Hayden HS, Hoffman L, Zheng H, Wahbeh G, Suskind DL. Reverse-engineered exclusive enteral nutrition in pediatric Crohn's disease: A pilot trial. J Pediatr Gastroenterol Nutr. 2024 May;78(5):1135-1142. doi: 10.1002/jpn3.12196. Epub 2024 Apr 1.
- Individual participant dataSharing planned: No. Not Discussed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale Y Lee, MD principal investigator
Seattle Children's Hospital and The University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional therapy in people with Crohn Disease, run by Dale Lee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal calprotectin <250 micrograms/gram (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508193, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.