Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-01 @ 9:49 PM
Study NCT ID:
NCT03510533
Status:
UNKNOWN
Last Update Posted:
2018-04-27
First Post:
2018-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054439', 'term': 'Ghrelin'}, {'id': 'D000521', 'term': 'alpha-MSH'}, {'id': 'D001069', 'term': 'Appetite Regulation'}, {'id': 'D049071', 'term': 'Endopeptidase Clp'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D009074', 'term': 'Melanocyte-Stimulating Hormones'}, {'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D001066', 'term': 'Appetite'}, {'id': 'D006815', 'term': 'Hunger'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D057065', 'term': 'ATP-Dependent Endopeptidases'}, {'id': 'D049069', 'term': 'ATP-Dependent Proteases'}, {'id': 'D000074183', 'term': 'ATPases Associated with Diverse Cellular Activities'}, {'id': 'D000074582', 'term': 'AAA Proteins'}, {'id': 'D017766', 'term': 'Acid Anhydride Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D000251', 'term': 'Adenosine Triphosphatases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D024101', 'term': 'Mitochondrial Proteins'}, {'id': 'D060365', 'term': 'Chloroplast Proteins'}, {'id': 'D010940', 'term': 'Plant Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eating disorders compared to healthy volonteers'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-26', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) involved in food intake regulation among patients with eating disorders', 'timeFrame': '1 week', 'description': 'blood samples collections'}], 'secondaryOutcomes': [{'measure': 'Scale for determination factors associated with eating disorders', 'timeFrame': '1 week', 'description': 'A global scale will evaluate :\n\n* socio demographic factors\n* somatic and psychiatric comorbidities\n* addictions\n* personal and family antecedents\n* major events'}, {'measure': 'statute in autoantibody and behavioral characteristics of the eating disorder', 'timeFrame': '1 week', 'description': 'quality of life and the psychological state of the patients tests'}, {'measure': 'Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB among patients presenting with eating disorders', 'timeFrame': '1 week', 'description': 'stoll samples collections'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autoantibodies (autoAc) circulating', "neuropeptides (Ghrelin, l'α-MSH)", 'potential digestive origin'], 'conditions': ['Eating Disorder']}, 'descriptionModule': {'briefSummary': 'This study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation.', 'detailedDescription': 'Eating disorders are a public health issue. It has been recently reported the importance of immune system modifications in eating disorders physiopathology, involving autoantibodies directed against neuropeptides regulating food intake. A recent study of laboratory INSERM 1073 showed the existence of an intestinal bacterial protein exhibiting structural similarities with α-MSH: ClpB. The autoAc directed against the latter also react with α-MSH because of these similarity of structures, thus leading to a potential digestive origin of these autoAc. To consolidate this new etiopathogenic assumption, a large clinical study is necessary with analysis of patients autoAc profiles. a monocentric study with inclusion of 240 patients over 2 years and 80 healthy volunteers is proposed.\n\nThis study should lead to the validation of the concept of the autoAc directed against the neuropeptides involved in food intake regulation. Nutritional modulations (probiotic, amino-acid…) could constitute an interesting therapeutic perspective in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with eating disorders\n\n1. 18 Years and older\n2. first clinical visit in nutrition department of CHU de Rouen for eating disorders\n3. anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V\n4. social security Affiliation\n5. Patient who signed the MEC approved informed consent\n\nVolunteers\n\n1. 18 Years to 60 Years\n2. body mass index ≥ 18,5 kg/m2 and ≤ 24,9 kg/m2\n3. negative SCOFF test\n4. No active and history of eating disorders\n5. social security Affiliation\n6. volunteer who signed the MEC approved informed consent\n\nExclusion criteria:\n\nPatients with eating disorders\n\n1. No anorexia nervosa, hyperphagia or bulimia according to the classification DSM-V\n2. Adults under legal protection or under safeguard of justice or administrative decision\n3. Pregnancy\n\nVolunteers\n\n1. Active or history of eating disorder\n2. Adults under legal protection or under safeguard of justice or administrative decision\n3. Pregnancy'}, 'identificationModule': {'nctId': 'NCT03510533', 'acronym': 'EDILS-AutoAC', 'briefTitle': 'Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Validation of the Concept of the Autoantibodies Directed Against the Neuropeptides Involved in Food Intake Regulation on the Incidental Cases of Eating Disorders', 'orgStudyIdInfo': {'id': '2016/107/HP'}, 'secondaryIdInfos': [{'id': '2017-A00875-48', 'type': 'OTHER', 'domain': 'Agence Nationale de Sécurité du médicament et des produits de Santé'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eating disorders patients', 'description': 'first clinical visit in nutrition department of CHU de Rouen for eating disorders (anorexia nervosa, hyperphagia or bulimia) according to the classification DSM-V', 'interventionNames': ['Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation']}, {'type': 'OTHER', 'label': 'healthy volunteers', 'description': 'Volunteers with negative SCOFF test (No active or history of eating disorders)', 'interventionNames': ['Other: Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation']}], 'interventions': [{'name': 'Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation', 'type': 'OTHER', 'otherNames': ['Evaluation of the rate of the autoantibodies directed against bacterial peptide, ClpB', 'Factors associated with eating disorders'], 'description': 'blood samples (12ml) and stool samples (30g) collections', 'armGroupLabels': ['Eating disorders patients', 'healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76031', 'city': 'Rouen', 'country': 'France', 'contacts': [{'name': 'Marie-Pierre TAVOLACCI, Ph, D', 'role': 'CONTACT', 'email': 'MP.Tavolacci@chu-rouen.fr', 'phone': '2 32 88 88 62', 'phoneExt': '+33'}], 'facility': "Centre d'Investigation Clinique", 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Najate EL MACHKOURI ACHAMRAH, MD, PhD', 'role': 'CONTACT', 'email': 'Najate.Achamrah@chu-rouen.fr', 'phone': '2 32 88 57 05', 'phoneExt': '+33'}, {'name': 'Pierre DECHELOTTE, Pr', 'role': 'CONTACT', 'email': 'Pierre.Dechelotte@chu-rouen.fr', 'phone': '2 32 88 64 65', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Najate EL MACHKOURI ACHAMRAH, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}