Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-05 @ 2:32 PM
Study NCT ID:
NCT03329534
Status:
UNKNOWN
Last Update Posted:
2018-03-21
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gluten Related Disorders in Barrett's Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055050', 'term': 'Diet, Gluten-Free'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-20', 'studyFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of non-acidic to acidic reflux events', 'timeFrame': 'At study start and at one month after a gluten free diet', 'description': 'Proportion of non-acid to acid reflux events as determined by pH-impedance'}], 'secondaryOutcomes': [{'measure': 'Reflux disease questionnaire', 'timeFrame': 'At study start and one month after a gluten free diet', 'description': '12 questions with six choices each. Results are added such that best score is 12 and worst score is 72.'}, {'measure': 'Esophageal motility', 'timeFrame': 'At study start', 'description': 'Manometric findings of the upper and lower sphincters and esophageal body'}, {'measure': 'Upper gastrointestinal motility', 'timeFrame': 'At study start', 'description': 'Fluoroscopic findings of gastroduodenal motility'}, {'measure': 'Leeds short form questionnaire', 'timeFrame': 'At study start and one month after a gluten free diet', 'description': 'Questionnaire for dyspepsia. Nine questions with five choices each. Only eight question scores are summed. Best score is 8 and worst score is 40.'}, {'measure': 'Gastroesophageal reflux disease-health related quality of life instrument', 'timeFrame': 'At study start and one month after a gluten free diet', 'description': '11 questions. Ten of them are summed with six choices each. The best score is 0 and the worst score is 50.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Celiac Disease', 'Barrett Esophagus', 'Gluten Sensitivity', 'GERD']}, 'descriptionModule': {'briefSummary': "In a small group of people gluten, a storage protein commonly in wheat and other grains, can cause gut inflammation and symptoms like diarrhea and abdominal pain. Gluten-related disorders include celiac disease (CD) and non-celiac gluten sensitivity (NCGS) and are treated by starting a gluten free diet (GFD). Patients with CD and NCGS also more commonly experience esophageal reflux and damage to the lining of the esophagus. A potential consequence of long-standing heartburn is Barrett's esophagus (BE), a major risk factor for cancer of the esophagus.\n\nThis study aims to investigate the mechanism that leads to reflux and BE in those with gluten related disorders, and to assess if a GFD is beneficial. We will study the upper gut function and reflux activity in patients with BE both with and without a GRD disorder. Testing will occur before and after a gluten free diet is instituted. The results will help inform health care providers and patients about the connection between gluten-related disorders, reflux, BE, and the role of GFD.", 'detailedDescription': "Perhaps patient's with gluten related disorders develop Barrett's esophagus due to non-acid reflux precipitated by upper gastrointestinal motility changes that respond to a gluten free diet; whereas patients without gluten related disorders develop Barrett's due to the accepted mechanism of acid reflux.\n\nThe primary objectives are to explore if patients with gluten-related disorders (CD and GS) may have an altered mechanism of developing Barrett's esophagus typified by increased alkali reflux compared to those without gluten-related disorders; and to determine if this mechanism (altered motility and increased non-acid reflux) responds to a gluten free diet.\n\nSpecific objectives include assessing whether patients with GRD and Barrett's esophagus have altered esophageal reflux extent, frequency, and type (assessed by pH-impedance); altered symptom profiles; differential esophageal body and sphincter pressures (assessed by manometry); aberrant gastroduodenal motility (assessed by videofluoroscopy) in comparison to patients with BE and no GRD. Finally a gluten free diet will be instituted to assess whether a gluten-free diet alters esophageal reflux extent, frequency, and type or symptom profiles in those with BE with and without a GRD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 years and over\n* Barrett's Esophagus diagnosis based on endoscopy and esophageal biopsies\n* Patients able to comply to the study procedures, according to the investigator's own judgment\n\nExclusion Criteria:\n\n* Patients who have been on a gluten free diet within the last six months\n* History of bariatric surgery, fundoplication, or gastrectomy (partial or complete)\n* Connective tissue disease\n* Concurrent organic GI pathology other than benign polyps, haemorrhoids, lipomas, H. pylori infection, diverticulosis, and melanosis coli\n* Chronic treatment with high dose opioids\n* Alcohol or drug abuse\n* Pregnant or breastfeeding women. Women enrolling in the study will be advised to avoid pregnancy during the course of the study by using adequate birth control such as abstinence, oral contraceptive pill, barrier contraceptives (i.e condom). If a subject becomes pregnant she will be withdrawn from the study.\n* Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection"}, 'identificationModule': {'nctId': 'NCT03329534', 'briefTitle': "Gluten Related Disorders in Barrett's Esophagus", 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': "Mechanisms Underlying Development of Barrett's Esophagus in Patients With Gluten Related Disorders", 'orgStudyIdInfo': {'id': 'GRD in BE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with GRDs', 'description': "An intervention of a change in diet, specifically a gluten free diet taught by a health care professional will be administered for one month's time.", 'interventionNames': ['Other: Gluten free diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects without GRDs', 'description': "An intervention of a change in diet, specifically a gluten free diet taught by a health-care professional will be administered for one month's time.", 'interventionNames': ['Other: Gluten free diet']}], 'interventions': [{'name': 'Gluten free diet', 'type': 'OTHER', 'description': 'A month long gluten free diet', 'armGroupLabels': ['Subjects with GRDs', 'Subjects without GRDs']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Premysl Bercik, MD', 'role': 'CONTACT', 'email': 'bercikp@mcmaster.ca', 'phone': '905 521 2100', 'phoneExt': '73495'}], 'overallOfficials': [{'name': 'Premysl Bercik, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}