Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT01595932
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2012-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D005414', 'term': 'Flatulence'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-09', 'studyFirstSubmitDate': '2012-05-09', 'studyFirstSubmitQcDate': '2012-05-09', 'lastUpdatePostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '5 weeks of observation', 'description': 'Global distress associated with gas-related symptoms (bloating, flatulance, abdominal distension and abdominal spasm): data collected by parents or patients on a daily diary chart, 3 time/daily by using a validated visual score scale (Faces Pain Scale-Revised).'}], 'secondaryOutcomes': [{'measure': 'Clinical tolerability', 'timeFrame': 'treatment: 2 weeks', 'description': 'Recording of all Adverse Events (AEs) occurred during the 2 weeks of treatment'}, {'measure': 'Efficacy', 'timeFrame': '5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)', 'description': 'Frequency and intensity (6 point scale: 0=absent; 5=very severe)of bloating, flatulance, visible distension, spasms.\n\nData were collected by parents or patients on a daily diary chart.'}, {'measure': 'Efficacy', 'timeFrame': '5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)', 'description': "Physician's overall evaluation: 4 point scale (from completed/marked improvement to worse)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['irritable bowel syndrome (IBS)', 'bloating', 'abdominal distension', 'flatulence', 'α-Galactosidase'], 'conditions': ['Gas Pain Related Intake']}, 'referencesModule': {'references': [{'pmid': '24063420', 'type': 'DERIVED', 'citation': 'Di Nardo G, Oliva S, Ferrari F, Mallardo S, Barbara G, Cremon C, Aloi M, Cucchiara S. Efficacy and tolerability of alpha-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2013 Sep 24;13:142. doi: 10.1186/1471-230X-13-142.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.', 'detailedDescription': 'Most patients with functional gastrointestinal disorders complain of gas-related symptoms which can negatively affect quality of life, even in pediatric age.\n\nDietary and life-style changes, administration of simethicone, activated charcoal and probiotics may reduce intestinal gas but often results are unsatisfactory.\n\nLiterature shows that α-galactosidase is effective to reduce gas production and related symptoms in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.\n\nExclusion Criteria:\n\n* suspected episodes of hypersensitivity or allergy;\n* chronic organic disorders (by clinical history, physical examination, laboratory tests);\n* use of drug affecting the GI motility during the previous 4 weeks;\n* inability of the parent to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator.'}, 'identificationModule': {'nctId': 'NCT01595932', 'briefTitle': 'Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Policlinico Umberto I'}, 'officialTitle': 'Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'α-galactosidase'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'α-galactosidase', 'interventionNames': ['Dietary Supplement: α-galactosidase']}], 'interventions': [{'name': 'α-galactosidase', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Sinaire'], 'description': 'Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks:\n\nchildren \\< 20kg: 4 drops;\n\nchildren \\> 20kg and \\< 40kg: 8 drops;\n\nchildren \\> 40kg: 1 tablet.', 'armGroupLabels': ['α-galactosidase']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks:\n\nchildren \\< 20kg: 4 drops;\n\nchildren \\> 20kg and \\< 40kg: 8 drops;\n\nchildren \\> 40kg: 1 tablet.', 'armGroupLabels': ['placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Policlinico Umberto I', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giovanni Di Nardo', 'investigatorAffiliation': 'Azienda Policlinico Umberto I'}}}}