Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 3:55 PM
Study NCT ID:
NCT03320369
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2017-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535952', 'term': 'Eosinophilic enteropathy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'n-gonzalves@northwestern.edu', 'phone': '312-695-4054', 'title': 'Nirmala Gonsalves', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From informed consent to cessation of treatment which is approximately 8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants in Complete Histologic Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks after treatment', 'description': 'Percent of patients who have achieved complete histologic remission. Complete histologic remission is defined as normalization of gastric mucosal eosinophilia (histology with less than the diagnostic threshold levels of mucosal eosinophilia (\\<30 eosinophils per high power field (HPF))', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Participants in Partial Histologic Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks after treatment', 'description': 'Percent of participants in partial histologic remission. Partial remission is defined as 50% or more reduction in the maximum of gastric and duodenal peak eosinophil count.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Maximum Eosinophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '63.1', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '75.5'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '-46.9', 'groupId': 'OG000', 'lowerLimit': '-59.1', 'upperLimit': '-34.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks after treatment', 'description': 'The maximum between gastric and duodenal eosinophil counts per high power field were obtained at baseline and 6 weeks. Mean change in count is defined as maximum eosinophil count per high power field (hpf) at 6 weeks minus maximum eosinophil count per hpf at baseline. A reduction (negative change from baseline) in eosinophil count per hpf indicates improvement. Eosinophil counts per hpf from gastric and duodenal biopsies were assessed by research pathologists at 400X magnification.', 'unitOfMeasure': 'eosinophil counts per high power field', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Gastric Endoscopic Reference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete'}], 'classes': [{'title': 'Baseline Endoscopic Score', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Change in Endoscopic Score', 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '-2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 weeks after treatment', 'description': 'The gastric endoscopic reference score utilizes standardized criteria for the presence and degree of major endoscopic features. Overall scores range from 0 - 10. Endoscopic features were assessed at baseline and 6 weeks. Change in overall endoscopic reference score is defined as overall score at 6 weeks minus overall score at baseline. A reduction (negative change) in score indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptoms of Dyspepsia (SODA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete'}], 'classes': [{'title': 'Baseline Pain', 'categories': [{'measurements': [{'value': '21.8', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '27.5'}]}]}, {'title': 'Baseline Non Pain', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '17.7'}]}]}, {'title': 'Baseline Satisfaction', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '12.3'}]}]}, {'title': 'Change in Pain', 'categories': [{'measurements': [{'value': '-6.9', 'groupId': 'OG000', 'lowerLimit': '-11.3', 'upperLimit': '-2.6'}]}]}, {'title': 'Change in Non Pain', 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '-0.1'}]}]}, {'title': 'Change in Satisfaction', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '8.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks after treatment', 'description': 'The SODA questionnaire captures symptoms associated with gastric dyspepsia including symptoms associated with "pain" and "non-pain" as well as general satisfaction with present symptoms. The scores range from 0 to 47 for pain; 0 to 35 for non-pain, and 0 to 23 for satisfaction. Higher scores indicate more frequent and/or severe symptoms for pain and non-pain. Higher scores indicate greater satisfaction. Scores were obtained at baseline and 6 weeks. Change in score is defined as total score at 6 weeks minus total score at baseline. A reduction (negative change) indicates improvement in pain and non-pain. An increase (positive change) indicates improvement in satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Promis Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete'}], 'classes': [{'title': 'Baseline Anxiety', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '58.0'}]}]}, {'title': 'Change in Anxiety', 'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks after treatment', 'description': 'The Promis 29 questionnaire was used to assess anxiety. The range of scores for the anxiety sub-domain is 4 - 20 (raw score) with T-scores ranging from 40 to 82. A higher T-score indicates greater anxiety. Scores were obtained at baseline and 6 weeks. Change in score is defined as total score at 6 weeks minus total score at baseline.', 'unitOfMeasure': 'T-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy\n\nElemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-10', 'size': 718058, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-03T11:49', 'hasProtocol': True}, {'date': '2020-05-01', 'size': 100864, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-03T11:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2017-10-12', 'resultsFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2017-10-20', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-03', 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants in Complete Histologic Remission', 'timeFrame': '6 weeks after treatment', 'description': 'Percent of patients who have achieved complete histologic remission. Complete histologic remission is defined as normalization of gastric mucosal eosinophilia (histology with less than the diagnostic threshold levels of mucosal eosinophilia (\\<30 eosinophils per high power field (HPF))'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants in Partial Histologic Remission', 'timeFrame': '6 weeks after treatment', 'description': 'Percent of participants in partial histologic remission. Partial remission is defined as 50% or more reduction in the maximum of gastric and duodenal peak eosinophil count.'}, {'measure': 'Mean Change From Baseline in Maximum Eosinophil Count', 'timeFrame': 'Baseline, 6 weeks after treatment', 'description': 'The maximum between gastric and duodenal eosinophil counts per high power field were obtained at baseline and 6 weeks. Mean change in count is defined as maximum eosinophil count per high power field (hpf) at 6 weeks minus maximum eosinophil count per hpf at baseline. A reduction (negative change from baseline) in eosinophil count per hpf indicates improvement. Eosinophil counts per hpf from gastric and duodenal biopsies were assessed by research pathologists at 400X magnification.'}, {'measure': 'Change From Baseline in Total Gastric Endoscopic Reference Score', 'timeFrame': 'Baseline, 6 weeks after treatment', 'description': 'The gastric endoscopic reference score utilizes standardized criteria for the presence and degree of major endoscopic features. Overall scores range from 0 - 10. Endoscopic features were assessed at baseline and 6 weeks. Change in overall endoscopic reference score is defined as overall score at 6 weeks minus overall score at baseline. A reduction (negative change) in score indicates improvement.'}, {'measure': 'Change From Baseline in Symptoms of Dyspepsia (SODA)', 'timeFrame': 'Baseline, 6 weeks after treatment', 'description': 'The SODA questionnaire captures symptoms associated with gastric dyspepsia including symptoms associated with "pain" and "non-pain" as well as general satisfaction with present symptoms. The scores range from 0 to 47 for pain; 0 to 35 for non-pain, and 0 to 23 for satisfaction. Higher scores indicate more frequent and/or severe symptoms for pain and non-pain. Higher scores indicate greater satisfaction. Scores were obtained at baseline and 6 weeks. Change in score is defined as total score at 6 weeks minus total score at baseline. A reduction (negative change) indicates improvement in pain and non-pain. An increase (positive change) indicates improvement in satisfaction.'}, {'measure': 'Change From Baseline in Promis Anxiety', 'timeFrame': 'Baseline, 6 weeks after treatment', 'description': 'The Promis 29 questionnaire was used to assess anxiety. The range of scores for the anxiety sub-domain is 4 - 20 (raw score) with T-scores ranging from 40 to 82. A higher T-score indicates greater anxiety. Scores were obtained at baseline and 6 weeks. Change in score is defined as total score at 6 weeks minus total score at baseline.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eosinophilic Gastroenteritis']}, 'referencesModule': {'references': [{'pmid': '37462600', 'type': 'DERIVED', 'citation': 'Gonsalves N, Doerfler B, Zalewski A, Yang GY, Martin LJ, Zhang X, Shoda T, Brusilovsky M, Aceves S, Thompson K, Rudman Spergel AK, Furuta G, Rothenberg ME, Hirano I. Prospective study of an amino acid-based elemental diet in an eosinophilic gastritis and gastroenteritis nutrition trial. J Allergy Clin Immunol. 2023 Sep;152(3):676-688. doi: 10.1016/j.jaci.2023.05.024. Epub 2023 Jul 18.'}], 'seeAlsoLinks': [{'url': 'http://www.rarediseasesnetwork.org/cms/CEGIR', 'label': 'Related info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis', 'detailedDescription': 'This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant must be able to understand and provide informed consent\n2. Males and Females ≥18 to 65 years of age;\n3. Have diagnosis of EG/EGE\n4. Have histologically confirmed active disease \\> 30 eosinophils/hpf\n5. Symptomatic (have experienced symptoms within the last one months prior to enrollment).\n6. Female subjects of childbearing potential must have a negative pregnancy test upon study entry\n7. Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study-specific methods may be listed, if applicable\n\nExclusion Criteria:\n\n1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n2. Secondary causes of gastrointestinal and peripheral eosinophilia\n3. Eosinophilic infiltration isolated to the esophagus.\n4. Pregnancy\n5. Immunodeficiency states\n6. Have been treated with topical swallowed steroids within the last 6 weeks or systemic steroids within the last 2 months unless repeat endoscopy is performed and shows active inflammation on these therapies in which case these medications will be allowed to be continued without dose escalation.\n7. Have taken immunosuppression medication or immunomodulators within 2 months of the study unless the recent/baseline endoscopy has active histologic inflammation while on these medications. In this case, these medications will be permitted to be continued as long as the dose is not escalated during the treatment phase.\n8. Have been on an elemental diet previously for six weeks with follow up endoscopy completed.\n9. Have participated in any investigative drug study within 6 weeks prior to study entry.\n10. Unable to complete study procedures including endoscopy.\n11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study."}, 'identificationModule': {'nctId': 'NCT03320369', 'briefTitle': 'Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis', 'orgStudyIdInfo': {'id': '2017-2766'}, 'secondaryIdInfos': [{'id': 'U54AI117804', 'link': 'https://reporter.nih.gov/quickSearch/U54AI117804', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'description': 'Elemental formula Intervention: Elemental Diet Therapy', 'interventionNames': ['Other: Elemental Diet Therapy']}], 'interventions': [{'name': 'Elemental Diet Therapy', 'type': 'OTHER', 'description': 'Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60208', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Nirmala Gonsalves, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Office of Rare Diseases (ORD)', 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}