Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05119218
Status:
COMPLETED
Last Update Posted:
2022-08-30
First Post:
2021-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gut Microbiota Stunted Children NTT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006130', 'term': 'Growth Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool and blood sampling'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-25', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '200 sample Gut Microbiota Profile descript OTU by NGS', 'timeFrame': '2 months', 'description': 'Profile of genus microbiota observed using Next Generation Sequencing'}], 'secondaryOutcomes': [{'measure': '200 sample Short Chain Fatty Acid Profile from feses sample', 'timeFrame': '1 months', 'description': 'microbiota metabolite profile'}, {'measure': '200 sample Gut Integrity profile from blood sample', 'timeFrame': '2 months', 'description': 'serum lipid binding protein, serum citrulline, serum Intestinal Fatty Acid Binding Protein (IFABP), serum Fatty Acid Binding Protein (FABP), sCD14, dan sCD163.'}, {'measure': '200 sample immune response from blood sample', 'timeFrame': '2 months', 'description': 'TNF, TGF, IL-10, dan sIgA'}, {'measure': '200 data hygiene practice from quenstionare data', 'timeFrame': '2 months', 'description': 'epidemiology data, daily hygiene practice, family data'}, {'measure': '200 cognitive development data from coqnitive measurement', 'timeFrame': '2 months', 'description': 'coqnitive descriptive'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stunting', 'Gut microbiota', 'toddler', 'SCFA', 'Parasite', 'Hygiene Practice'], 'conditions': ['Stunting']}, 'referencesModule': {'references': [{'pmid': '34324500', 'type': 'BACKGROUND', 'citation': 'Surono IS, Jalal F, Bahri S, Romulo A, Kusumo PD, Manalu E, Yusnita, Venema K. Differences in immune status and fecal SCFA between Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jul 29;16(7):e0254300. doi: 10.1371/journal.pone.0254300. eCollection 2021.'}, {'pmid': '33497390', 'type': 'RESULT', 'citation': 'Surono IS, Widiyanti D, Kusumo PD, Venema K. Gut microbiota profile of Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jan 26;16(1):e0245399. doi: 10.1371/journal.pone.0245399. eCollection 2021.'}, {'pmid': '40716760', 'type': 'DERIVED', 'citation': 'Surono IS, Athiyyah AF, Venema K. Gut microbiota, SCFA and nutritional intake in stunted children in East Nusa Tenggara, Indonesia. Benef Microbes. 2025 Jul 24;16(6):647-658. doi: 10.1163/18762891-bja00090.'}, {'pmid': '38551926', 'type': 'DERIVED', 'citation': 'Surono IS, Popov I, Verbruggen S, Verhoeven J, Kusumo PD, Venema K. Gut microbiota differences in stunted and normal-lenght children aged 36-45 months in East Nusa Tenggara, Indonesia. PLoS One. 2024 Mar 29;19(3):e0299349. doi: 10.1371/journal.pone.0299349. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'NTT Province is on the list of priority areas of high prevalence of stunting, Southwest Sumba, South Middle East, and Kupang district have a stunting prevalence of 36.2%, 34.5% and 48.1% respectively in 2020. Therefore, it is necessary to conduct a profile study. microbiota, SCFA, gastrointestinal integrity, parasites, hygiene practice, and cognition in stunting and healthy toddlers in the province of East Nusa Tenggara,', 'detailedDescription': "Stunting indicates a public health problem because it is associated with an increased risk of morbidity and mortality, decreased motor and mental function development, and reduced physical capacity. Stunting is a chronic nutritional deficiency condition that affects the growth and development, and intelligence of children. Lack of nutrients can cause intestinal microbiota dysbiosis where this will reduce the metabolism of short chain fatty acids (SCFA) which will affect the absorption of nutrients in the small intestine and cause impaired immunity, which in turn worsens stunting conditions. The composition of the gut microbiota is influenced by age, sex, geographic area and food intake. Therefore, the description of knowledge, attitudes and applications in society, especially mothers and child subjects, was also analyzed using a hygiene practice questionnaire. The aim of the study was to obtain an overview of the gut microbiota, gastrointestinal integrity, parasitic infections, hygiene practices and cognitive scores in stunting and healthy toddlers in several areas in the province of East Nusa Tenggara as a baseline study to be followed up by intervention study.\n\nThe research will be conducted for 3 (three) months in 2021/2022. The subjects involved represented 100 stunted children and 100 healthy children aged 36-45 months from each region. Determination of the sample with a sampling quota. The variables studied were the nutritional status of under five years children, characteristics of children under five (age, gender, birth weight (BBL), birth length, breast feeding history, immunization history, history of diarrhea, history of ARI (Upper Respiratory Tract Infection)), mother and family characteristics (age, education). , occupation, father's occupation, total family income), home environment and hygiene, vaccination history, gastrointestinal microbiota status, gastrointestinal integrity, parasites, hygiene practices, and cognitive scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '45 Months', 'minimumAge': '36 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This observational study used a cross sectional design with a quantitative approach. The cross-sectional research design is a research conducted at one time and one time to find the relationship between the independent variable (risk factor) and the dependent variable (effect) as baseline data', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anthropometric measurements of stunting were measured based on the parameters of length/height according to age compared to the 2005 WHO anthropometric standards and the Indonesian Ministry of Health Decree No. 1995/MENKES/SK/XII/2010.\n\nExclusion Criteria:\n\n* criteria thats makes subject appropiate, like more than 5 years old, not live in sampling area, unhealthy'}, 'identificationModule': {'nctId': 'NCT05119218', 'briefTitle': 'Gut Microbiota Stunted Children NTT', 'organization': {'class': 'OTHER', 'fullName': 'Bina Nusantara University'}, 'officialTitle': 'Gut Microbiota Profile, SCFA, Gut Integrity, Parasite Infection, Hygiene Practice and Cognitive Score on Stunted Children in East Nusa Tenggara', 'orgStudyIdInfo': {'id': '332/KEP-UY/BIA/X/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stunted subject', 'description': 'The population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 stunting toddlers toddlers in each area.', 'interventionNames': ['Other: No Intervention']}, {'label': 'Normal subject', 'description': 'The population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 non-stunted toddlers in each area.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['Normal subject', 'Stunted subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11480', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'University', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Ingrid S Surono, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bina Nusantara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'planned not to be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bina Nusantara University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia', 'class': 'OTHER_GOV'}, {'name': 'Maastricht University', 'class': 'OTHER'}, {'name': 'Universitas Airlangga', 'class': 'OTHER'}, {'name': 'Yarsi University', 'class': 'UNKNOWN'}, {'name': 'Universitas Kristen Indonesia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ingrid S Surono', 'investigatorAffiliation': 'Bina Nusantara University'}}}}