Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-03 @ 8:20 PM
Study NCT ID:
NCT04028258
Status:
UNKNOWN
Last Update Posted:
2020-03-09
First Post:
2019-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-07-19', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool.', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Combined score between this parameters'}], 'secondaryOutcomes': [{'measure': 'Consistency of stool according to Bristol Stool Form Scale', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Valuation of stool characteristics (Bristol scale): 7 types of consistency, where type 1 is the hardest consistency.'}, {'measure': 'Frequency of stool', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Equal to or more than 3 times/week, 1-2 times/week, less than 1 time/week'}, {'measure': 'Change in stool weight', 'timeFrame': 'From baseline to 8 weeks', 'description': 'Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15%'}, {'measure': 'Gastrointestinal symptoms related to the constipation', 'timeFrame': 'From baseline to 8 weeks', 'description': "Record in the patient's dairy all the gastrointestinal symptoms during the study"}, {'measure': 'Adherence record to the complement intake (Moriski Green test)', 'timeFrame': 'At 8 weeks', 'description': '4 questions to the patient about treatment adherence.Patients who follow treatment are considered to be those who answer NO to the four questions and not to those who answer YES to one or more.'}, {'measure': 'Patient anthropometric measures: weight', 'timeFrame': 'Up to 8 weeks', 'description': 'Anthropometric records: weight (Kg)'}, {'measure': 'Patient anthropometric measures: size', 'timeFrame': 'Up to 8 weeks', 'description': 'Anthropometric records: size (cm)'}, {'measure': 'Patient anthropometric measures: waist perimeter', 'timeFrame': 'Up to 8 weeks', 'description': 'Waist perimeter (cm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Constipation', 'Fiber'], 'conditions': ['Constipation - Functional']}, 'descriptionModule': {'briefSummary': 'Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence:\n\n* Group A: study product+wash out+control product\n* Group B: control product+wash out+study product', 'detailedDescription': 'All patients will be given guidelines for adopting dietary habits and healthy lifestyles to achieve a regular and physiological depositional rhythm and will be given a study supplement and a control supplement, alternatively, for 2 time periods of 3 weeks separated by 2 weeks of wash out.\n\n* Supplement under study: mixture of food fibers of plant origin, in a proportion that contributes 75% soluble fiber / 25% insoluble fiber.\n* Control: Placebo supplement: maltodextrin and plum flakes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Boys and girls aged 3 to 12\n* Diagnosis of functional constipation according to Rome IV criteria\n\nExclusion Criteria:\n\n* Regular use of a dietary fiber supplement, prebiotics or probiotics in the previous 30 days, or who would have been taking bulk-forming agents or laxatives in the 2 weeks prior to the study\n* Use of medications that cause constipation\n* Children with organic constipation such as Hirschsprung's disease, cerebral paralysis, anorectal and spinal cord abnormalities and metabolic diseases.\n* Patients who are not likely to complete follow-up"}, 'identificationModule': {'nctId': 'NCT04028258', 'acronym': 'VEGY-DOWN(A)', 'briefTitle': 'Effect of a Mixture of Fibers and Carbohydrates on Intestinal Transit in Children Diagnosed With Functional Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratorios Ordesa'}, 'officialTitle': 'Randomized, Controlled, Crossover, Double-blind Clinical Trial on the Effect of a Mixture of Plant-based Fibers and Carbohydrates on Intestinal Transit in Children Aged 3 to 12 Diagnosed With Functional Constipation', 'orgStudyIdInfo': {'id': 'VEGY-DOWN (A)-05-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A: study+wash out+control', 'description': 'Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks)', 'interventionNames': ['Dietary Supplement: Mixture of fibers + Placebo']}, {'type': 'OTHER', 'label': 'Group B: control+wash out+study', 'description': 'Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks)', 'interventionNames': ['Dietary Supplement: Placebo + Mixture of fibers']}], 'interventions': [{'name': 'Mixture of fibers + Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)', 'armGroupLabels': ['Group A: study+wash out+control']}, {'name': 'Placebo + Mixture of fibers', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)', 'armGroupLabels': ['Group B: control+wash out+study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22006', 'city': 'Huesca', 'state': 'Aragon', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jorge Fuertes, MD', 'role': 'CONTACT', 'phone': '974 225 450'}], 'facility': 'Centro de Salud Perpetuo Socorro', 'geoPoint': {'lat': 42.13615, 'lon': -0.4087}}, {'zip': '50018', 'city': 'Zaragoza', 'state': 'Aragon', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Isabel Lostal, MD', 'role': 'CONTACT', 'phone': '976 547 499'}], 'facility': 'Centro de Salud Amparo Poch', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': '39002', 'city': 'Santander', 'state': 'Cantabria', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Rosa Pardo', 'role': 'CONTACT', 'phone': '942218161'}], 'facility': 'Centro de Salud Isabel II', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'centralContacts': [{'name': 'Roser De Castellar, MD', 'role': 'CONTACT', 'email': 'Roser.DeCastellar@ordesa.es', 'phone': '+34 902105243'}], 'overallOfficials': [{'name': 'Gerardo Rodríguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Investigación Sanitaria Aragón'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratorios Ordesa', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}