Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-29 @ 9:29 PM
Study NCT ID:
NCT05291559
Status:
COMPLETED
Last Update Posted:
2022-09-10
First Post:
2022-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-21', 'lastUpdatePostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in appetite', 'timeFrame': 'Baseline to 14 days', 'description': "Parents will complete a study specific survey which will include questions about child's interest in food and food intake which will yield an appetite score."}, {'measure': 'Change in gastrointestinal health', 'timeFrame': 'Baseline to 14 days', 'description': "Parents will complete a study specific survey which will include questions about child's gastrointestinal symptoms such as diarrhea, vomiting, nausea, bloating, or constipation to yield a gastrointestinal health score."}, {'measure': 'Change in 2 hour Lactulose mannitol ratio', 'timeFrame': 'Baseline to 14 days', 'description': 'Assessment of Lactulose mannitol ratio at baseline and day 14'}], 'secondaryOutcomes': [{'measure': 'Residual intervention volume', 'timeFrame': '14 days', 'description': 'Summation of daily residual volume of unconsumed study product'}, {'measure': 'Fecal lactoferrin', 'timeFrame': '14 days', 'description': 'Assessment of fecal lactoferrin concentration at baseline and day 14'}, {'measure': 'Fecal myeloperoxidase', 'timeFrame': '14 days', 'description': 'Assessment of fecal myeloperoxidase concentration at baseline and day 14'}, {'measure': 'Fecal neopterin', 'timeFrame': '14 days', 'description': 'Assessment of fecal neopterin concentration at baseline and day 14'}, {'measure': 'Fecal Reg 1 beta', 'timeFrame': '14 days', 'description': 'Assessment of fecal Reg 1 beta concentration at baseline and day 14'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Environmental Enteric Dysfunction']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on efficacy will also be obtained.', 'detailedDescription': 'Primary Objectives\n\n1. To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age\n2. To assess the efficacy of Enterade (VS001) in treatment of environmental enteric dysfunction by comparing improvements in 2-h lactulose mannitol ratio between Enterade (VS001) and a placebo.\n\nSecondary Objectives\n\n1. To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children aged 1 to 2 years.\n2. To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of intestinal inflammation between Enterade (VS001) and placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Length-for-age Z score (LAZ) between -1 and -3 standard deviations\n* Lactulose mannitol ratio \\>0.09\n\nExclusion Criteria:\n\n* Presence of known congenital or chronic diseases other than malnutrition\n* Diarrhea (\\> 3 unformed stools in a 24-hour window) in the 7 days prior to screening\n* Anticipated unavailability for study visits\n* A sibling previously enrolled in this study'}, 'identificationModule': {'nctId': 'NCT05291559', 'briefTitle': 'Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh', 'orgStudyIdInfo': {'id': 'HM20023567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enterade (VS001)', 'description': '237 mL (8 fluid oz) per os, once daily for 14 days', 'interventionNames': ['Dietary Supplement: Enterade']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '237 mL (8 fluid oz) per os, once daily for 14 days', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Enterade', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['VS001'], 'description': 'Enterade is a glucose-free, amino acid-based medical food containing specific amino acids (aspartic acid, valine, serine, threonine and tyrosine) in addition to electrolytes and a non-sugar sweetener.', 'armGroupLabels': ['Enterade (VS001)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The placebo is an identical product to Enterade except without added amino acids.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Jeffrey R Donowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}