Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT01881360
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2013-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change, between baseline and endpoint, in the number of experienced celiac-type symptoms', 'timeFrame': '0, 4, 8, 12, 18 and 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change, between baseline and endpoint, in the Body Mass Index', 'timeFrame': '0, 4, 8, 12, 18 and 24 weeks'}, {'measure': 'Change, between baseline and endpoint, in the Revised Fibromyalgia Impact Questionnaire total score', 'timeFrame': '0, 4, 8, 12, 18 and 24 weeks'}, {'measure': 'Change, between baseline and endpoint, in the Pittsburgh Sleep Quality Index', 'timeFrame': '0, 4, 8, 12, 18 and 24 weeks'}, {'measure': 'Change, between baseline and endpoint, in the Brief Pain Inventory', 'timeFrame': '0, 4, 8, 12, 18 and 24 weeks'}, {'measure': 'Change, between baseline and endpoint, in the Beck Depression Inventory', 'timeFrame': '0, 4, 8, 12, 18 and 24 weeks'}, {'measure': 'Change, between baseline and endpoint, in the Short-form Health Survey', 'timeFrame': '0, 4, 8, 12, 18 and 24 weeks'}, {'measure': 'Change, between baseline and endpoint, in the State-Trait Anxiety Inventory', 'timeFrame': '0, 4, 8, 12, 18, 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fibromyalgia', 'celiac-type symptoms', 'gluten-free diet', 'hypocaloric diet'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic celiac disease or non-celiac gluten intolerance. The objective of this study is to compare the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and celiac-type symptoms.', 'detailedDescription': 'Fibromyalgia, a chronic pain disorder, is characterized by generalized chronic musculoskeletal pain that is usually accompanied by several other clinical manifestations that contribute to a diminished quality of life, such as sleep disturbances, chronic fatigue, mood disorders, and cognitive difficulties. Many patients with fibromyalgia suffer from gastrointestinal and extra-intestinal symptoms that are similar to those experienced by adult celiac disease patients such as abdominal pain, dyspepsia, nausea, diarrhea, constipation, fatigue, pain and mood changes. This raises the possibility that some patients with fibromyalgia may also suffer from oligosymptomatic celiac disease or non-celiac gluten intolerance. On the other hand, the emerging evidence linking obesity with fibromyalgia and the high prevalence of overweight among fibromyalgia patients suggest a potential benefit for weight loss among these patients. Thus, the main objective of this study is to compare the efficacy of a gluten-free diet (GFD) with a hypocaloric diet (HCD) in patients with fibromyalgia that also experience celiac-type symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients diagnosed with fibromyalgia according to the 1990 American College of Rheumatology diagnostic criteria.\n* Patients who successfully complete the screening process for sufficient celiac-type symptoms\n* Negative transglutaminase antibodies serological testing.\n* Signed informed consent to participate\n\nExclusion Criteria:\n\n* Patients suffering from any disease that could prevent them from following any of the suggested diet protocols\n* Current or previous history of substance abuse\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT01881360', 'briefTitle': 'Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Comparison Between a Gluten-free Diet and a Hypocaloric Diet for the Treatment of Patients With Fibromyalgia and Celiac-type Symptoms', 'orgStudyIdInfo': {'id': 'FMS-GFD-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gluten-free diet', 'interventionNames': ['Other: Gluten-free diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypocaloric diet', 'interventionNames': ['Other: Hypocaloric diet']}], 'interventions': [{'name': 'Gluten-free diet', 'type': 'OTHER', 'description': 'A diet that is free of the gluten component', 'armGroupLabels': ['Gluten-free diet']}, {'name': 'Hypocaloric diet', 'type': 'OTHER', 'description': 'A standard hypocaloric diet with a daily 1500 caloric intake.', 'armGroupLabels': ['Hypocaloric diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18012', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Instituto de Neurociencias "Federico Oloriz"', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Elena P. Calandre, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Responsible of the CTS-502 Investigation Team', 'investigatorFullName': 'Elena Pita Calandre', 'investigatorAffiliation': 'Universidad de Granada'}}}}