Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT03508193
Status:
COMPLETED
Last Update Posted:
2022-11-21
First Post:
2018-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reverse Engineering of Exclusive Enteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044623', 'term': 'Nutrition Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fecal calprotectin <250 micrograms/gram', 'timeFrame': '4 weeks', 'description': 'surrogate marker of intestinal inflammation'}], 'secondaryOutcomes': [{'measure': 'Quality of life as measured by IMPACT III Questionnaire', 'timeFrame': '4 weeks', 'description': 'validated quality of life measure for pediatric inflammatory bowel disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exclusive Enteral Nutrition', 'Nutrition', 'Diet', 'Inflammatory Bowel Disease'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '16162683', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '25970545', 'type': 'BACKGROUND', 'citation': "Lee 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."}, {'pmid': '38558411', 'type': 'DERIVED', 'citation': "Lee 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."}]}, 'descriptionModule': {'briefSummary': "Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease.\n\nSecondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls.\n\nThe specific aims of this proposal are:\n\n1. 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.\n2. To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease.\n3. To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 8 -21 years old\n2. Diagnosis of Crohn's disease within 4 weeks of study entry\n3. Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.\n4. Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent\n\nExclusion Criteria:\n\n1. History of surgery for Crohn's disease\n2. Perianal disease as part of Crohn's disease phenotype\n3. Prior treatment with EEN or the specific carbohydrate for Crohn's disease\n4. Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha agent, azathioprine, methotrexate, etc.)\n5. Prior treatment with antibiotics for Crohn's disease\n6. Known allergies to any of the food components in the smoothie\n7. Admission to hospital due to severity of Crohn's disease and associated symptoms\n8. Unwillingness to provide informed consent"}, 'identificationModule': {'nctId': 'NCT03508193', 'acronym': 'RE-EEN', 'briefTitle': 'Reverse Engineering of Exclusive Enteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': "Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease", 'orgStudyIdInfo': {'id': 'STUDY00000619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Whole-foods based smoothie as nutritional therapy', 'interventionNames': ['Other: Nutritional therapy']}], 'interventions': [{'name': 'Nutritional therapy', 'type': 'OTHER', 'description': 'Whole-foods based smoothie designed to emulate formulas used in EEN', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Dale Y Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital and The University of Washington"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not Discussed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dale Lee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Dale Lee', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}