Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT05396651
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2022-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092622', 'term': 'FODMAP Diet'}], 'ancestors': [{'id': 'D000092724', 'term': 'Elimination Diets'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2022-03-06', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of irritable bowel syndrome symproms', 'timeFrame': '6 weeks', 'description': 'Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score'}], 'secondaryOutcomes': [{'measure': 'improve patients quality of life', 'timeFrame': '6 weeks', 'description': 'Change in Pediatric quality of life inventory (PEDSQL) Generic core l score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of low FODMAP diet on Health related Quality of life in children with Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric Hospital at Ain Shams University', 'detailedDescription': 'Single blinded randomized two-arm intervention study in which 42 patients with irritable bowel syndrome were enrolled to study the effect of LOW FODMAP diet ( intervention group) on their gastrointestinal symptoms and their quality of life another group of 42 patients of IBS were enrolled as a control group who were received general diet instructions and they followed the NICE guide lines for IBS management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis\n\nExclusion Criteria:\n\nPatients presenting with :\n\n* Abdominal pain or diarrhea that wakes the child from sleep\n* Delay in onset or progression of puberty.\n* Faltering growth.\n* Family history of inflammatory bowel disease, celiac disease.\n* History of significant weight loss .\n* Bleeding per rectum.\n* Persistence of severe vomiting or diarrhea\n* . Persistent joint pain.\n* Recurrent unexplained fever.\n* Unexplained pallor'}, 'identificationModule': {'nctId': 'NCT05396651', 'briefTitle': 'Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Effect of Low Fodmap Diet on Control of Pediatric Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'FMASU319/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LOW FODMAP Diet group', 'description': "42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis, and didn't have any of the following :o Abdominal pain or diarrhea that wakes the child from sleep\n\n* Delay in onset or progression of puberty.\n* Faltering growth.\n* Family history of inflammatory bowel disease, celiac disease.\n* History of significant weight loss .\n* Bleeding per rectum.\n* Persistence of severe vomiting or diarrhea\n* . Persistent joint pain.\n* Recurrent unexplained fever.\n* Unexplained pallor they followed the low fodmapdiet for 6 weeks", 'interventionNames': ['Other: low fodmap diet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NICE guidelines group', 'description': "42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis and didn't have one of the following : o Abdominal pain or diarrhea that wakes the child from sleep\n\n* Delay in onset or progression of puberty.\n* Faltering growth.\n* Family history of inflammatory bowel disease, celiac disease.\n* History of significant weight loss .\n* Bleeding per rectum.\n* Persistence of severe vomiting or diarrhea\n* . Persistent joint pain.\n* Recurrent unexplained fever.\n* Unexplained pallor\n\nthey followed NICE guidelines for irritable bowel syndrome for 6 weeks", 'interventionNames': ['Other: NICE guidelines for IBS']}], 'interventions': [{'name': 'low fodmap diet', 'type': 'OTHER', 'description': 'elimination of high fodmap diet - High FODMAP diet: ice cream, soft cheese , yoghurt, cabbage , cauliflower, green bean, garlic, okra, onions, snow peas, broccoli, avocado , apple, mango , dates, watermelon, legumes , pulses, wheat , pasta , artificial sweeteners', 'armGroupLabels': ['LOW FODMAP Diet group']}, {'name': 'NICE guidelines for IBS', 'type': 'OTHER', 'description': 'follow NICE guidelines for IBS :have regular meals and take time to eat. avoid missing meals or leaving long gaps between eating. drink at least 8 cups of fluid per day, especially water or other non-caffeinated drinks, for example herbal teas.\n\nrestrict tea and coffee to 3 cups per day. reduce intake of alcohol and fizzy drinks.', 'armGroupLabels': ['NICE guidelines group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1234', 'city': 'Cairo', 'state': 'Abbasia', 'country': 'Egypt', 'facility': 'Faculty of Medicine Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Diaa a Marzouk, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of medicine ain shams university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarah Abdelrahman El Ezaby', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Family Medicine assistant lecturer at Faculty of Medicine', 'investigatorFullName': 'Sarah Abdelrahman El Ezaby', 'investigatorAffiliation': 'Ain Shams University'}}}}