Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-26 @ 4:15 PM
Study NCT ID:
NCT01789294
Status:
UNKNOWN
Last Update Posted:
2013-02-12
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '2013-02-06', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '8 weeks', 'description': 'to identify an appropriate management approach for LNH by evaluation of clinical severity and response.\n\nClinical severity at time 0 and 1 was assessed by Pediatric Gastroenterologists blinded to allocation concealment. Basing on standardized Childhood behaviour checklists questionaire compiled by parents, symptoms were graded using a validated score of abdominal pain (from 0 to 12).\n\nClinical response was defined as the improvement of at least 1 point in symptom scores from time 0 to 1.'}], 'secondaryOutcomes': [{'measure': 'predictive factors', 'timeFrame': '8 weeks', 'description': 'we evaluated whether symptoms severity, site of LNH, presence of food sensitization and predisposition to atopy, should be predictive for the clinical response'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lymphoid nodular hyperplasia', 'food allergy'], 'conditions': ['Intestinal LNH']}, 'descriptionModule': {'briefSummary': 'Aim of this prospective, parallel multi-arm, randomized, clinical trial, was to compare the clinical outcome of patients Methods.We recruited children who undergone diagnostic colonoscopy in Umberto I Pediatric Department (Rome, Italy) from 2008 to 2010. Eligibility criteria were: 1) only demonstration of LNH; 2) no concomitant disease; 3) no treatment assumed since the clinical onset. Patients were allocated 1:1:1 to dietetic (Group A) vs mesalamine (Group B) vs no treatment (Group C) for a 8-weeks period. Skin prick tests and patch test for common foods, and symptoms scoring at baseline and follow up have been performed by blinded clinicians. Chi-square test for trend was used to compare the frequency of symptoms score improvement (\\>1 point) among groups. The association of baseline features of patients with the clinical response was estimated by frequency analysis.', 'detailedDescription': 'Lymphoid nodular hyperplasia (LNH) of the lower gastrointestinal tract is a common finding in pediatric colonoscopies, whose clinical significance is not yet been clearly established. Although initially considered to be a normal, age-related variant, some authors recently suggested to regard LNH as a marker of food allergy (FA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. isolated finding of LNH\\[18\\], defined as the demonstration of a significant cluster of lymphoid nodules (\\>10/visible field) by endoscopy and lymphoid follicle hyperplasia by hystology;\n2. negative results of preliminary evaluation\n\nExclusion Criteria:\n\n1. diagnosis of concomitant inflammatory, rheumatic or infectious disease, and\n2. the assumption of any dietetic or therapy since the clinical onset.'}, 'identificationModule': {'nctId': 'NCT01789294', 'briefTitle': 'Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Policlinico Umberto I'}, 'officialTitle': 'CLINICAL MANAGEMENT OF CHILDHOOD INTESTINAL LYMPHOID NODULAR HYPERPLASIA: A RANDOMIZED CONTROLLED CLINICAL TRIAL.', 'orgStudyIdInfo': {'id': 'ped-LNH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesalamine', 'description': 'A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects', 'interventionNames': ['Drug: Mesalamine']}, {'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'A close clinical observation without therapy was taken in control patients, whom parents were alerted to refer immediately if symptoms persisted or get worse.'}, {'type': 'EXPERIMENTAL', 'label': 'DIET', 'description': "Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists", 'interventionNames': ['Behavioral: DIET']}], 'interventions': [{'name': 'Mesalamine', 'type': 'DRUG', 'description': 'A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects. Whether the drug was not well tolerated, patients were drop out. Treatment was discontinued at time 1 to look for symptom recurrence.', 'armGroupLabels': ['Mesalamine']}, {'name': 'DIET', 'type': 'BEHAVIORAL', 'description': "Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists. To ensure the correct adherence to diet with no nutritional impairment, a scheme of admitted foods and an appropriate calcium supplement dose were given to patients.", 'armGroupLabels': ['DIET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Di Nardo, MD', 'role': 'CONTACT', 'email': 'giovanni.dinardo@uniroma1.it', 'phone': '+390649979326'}], 'facility': 'Departments of Pediatrics, Sapienza - University of Rome', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Giovanni Di Nardo, MD', 'role': 'CONTACT', 'email': 'giovanni.dinardo@uniroma1.it', 'phone': '+390649979326'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Policlinico Umberto I', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giovanni Di Nardo', 'investigatorAffiliation': 'Azienda Policlinico Umberto I'}}}}