Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-23 @ 1:10 AM
Study NCT ID:
NCT04698759
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2021-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune and Scfa Profile of Stunting Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D006130', 'term': 'Growth Disorders'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample with plasma and serum preparation Fecal sample with DNA extraction Fecal sample with SCFA preparation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Microbiota profile', 'timeFrame': '2 months', 'description': 'relative abundance microbiota profile'}], 'primaryOutcomes': [{'measure': 'TGF beta', 'timeFrame': '1 week analysis', 'description': 'Unit : pg/mL from serum'}, {'measure': 'sIgA', 'timeFrame': '1 week analysis', 'description': 'Unit : ul/ml from feses extract'}, {'measure': 'IL -10', 'timeFrame': '1 week analysis', 'description': 'unit pg/ml from serum'}, {'measure': 'TNF alfa', 'timeFrame': '1 week analysis', 'description': 'unit pg/mL from serum'}, {'measure': 'LBP', 'timeFrame': '1 week analysis', 'description': 'Unit ul/ml from serum'}], 'secondaryOutcomes': [{'measure': 'Short Chain Fatty Acid', 'timeFrame': '1 months', 'description': 'Acetate, Propionate, Butyrate, Isobutyric, Isopropionic , unit mM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immune status', 'stunting', 'Normal Nutritional Status', 'Indonesian Children', 'Gut Microbiota', 'SCFA'], 'conditions': ['Immune Deficiency', 'Stunting', 'Fatty Acid']}, 'referencesModule': {'references': [{'pmid': '17208643', 'type': 'BACKGROUND', 'citation': 'Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4.'}, {'pmid': '31109058', 'type': 'RESULT', 'citation': 'Titaley CR, Ariawan I, Hapsari D, Muasyaroh A, Dibley MJ. Determinants of the Stunting of Children Under Two Years Old in Indonesia: A Multilevel Analysis of the 2013 Indonesia Basic Health Survey. Nutrients. 2019 May 18;11(5):1106. doi: 10.3390/nu11051106.'}, {'pmid': '34324500', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '1. Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).\n2. Time and Location of Research The research will be conducted for approximately six months in 2020 at Banten Regency (namely Tegal Ongok and Pasirkarang) and Sumedang Regency.\n3. Population and Research Sample The population is children between three and five years old in the village of stunting locus.\n\nThe sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each Regency.', 'detailedDescription': "The variables studied will be the nutritional status of children between three and five years old, the characteristics of these children (age, sex, LBW, birth length, history of immunization, history of diarrhea, history of upper respiratory tract infection, food intake), mother and family characteristics (mother's age, mother's education, mother's occupation, father's occupation), home environment (aspects of the components of the house, aspects of sanitation facilities, aspects of occupant behavior), the composition of the intestinal microbiota. Data will be obtained through measurements, interviews using a questionnaire, and direct observation using a checklist.\n\nStunting anthropometric measurements are measured based on parameters of length/height according to age compared to the WHO anthropometric standards 2005 and the Indonesian Minister of Health Decree No. 1995 / MENKES / SK / XII / 2010.\n\nThe nutritional status of each child included in this study will be quantified using the WHO recommended three nutritional Z-scores namely, height for age (referred to in this study as Zscore\n\n1. weight for age (referred as Z-score\n2. and weight for height (referred as Z-score\n3. .A structured questionnaire was used for face-to-face interviews with the respective child mother to collect sociodemographic information. In addition, age and anthropometric measurements (height, weight) based on the Department of Health Ministry of Indonesia The regulation will be recorded. For stunting, the thresholds for height-for-age are: 'severely stunted' (\\<-3 SD); 'stunted' (-3 SD to \\< -2 SD); 'normal' (-2 SD to +3 SD); 'tall' (\\> +3 SD). Furthermore, in order to obtain an overall measure of the nutritional status of these children, the children will be classified into weight-for-height categories: 'severely wasted' (\\<-3 SD); 'wasted' (-3 SD to \\< -2 SD); 'normal' (-2 SD to +1 SD); 'possible risk of overweight' (+1 SD to +2 SD); 'overweight' (\\> +2 SD to +3 SD); 'obese' (\\> +3 SD)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '.A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children age : 3 - 5 years old (36-60 months)\n* Live in the research area\n* Apparently healthy children, after examination by a physician\n* Involved in a research study (informed consent signed by parent or guardian)\n\nExclusion Criteria:\n\n* Children age \\< 36 month and \\> 60 month\n* Live outside research area\n* Unhealthy, after examination by a physician'}, 'identificationModule': {'nctId': 'NCT04698759', 'briefTitle': 'Immune and Scfa Profile of Stunting Children', 'organization': {'class': 'OTHER', 'fullName': 'Bina Nusantara University'}, 'officialTitle': 'Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status', 'orgStudyIdInfo': {'id': 'No.026/VR.RTT/IV/202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stunted subject', 'description': 'Children with stunted status condition based on Z score criteria', 'interventionNames': ['Other: No Intervention']}, {'label': 'Normal subject', 'description': 'Children with normal status condition based on Z score criteria', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'no Intervention', 'armGroupLabels': ['Normal subject', 'Stunted subject']}]}, 'contactsLocationsModule': {'locations': [{'city': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bina Nusantara University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yayasan Rumah Sakit Islam (YARSI) University', 'class': 'UNKNOWN'}, {'name': 'Universitas Kristen Indonesia', 'class': 'OTHER'}, {'name': 'Maastricht University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ingrid S Surono', 'investigatorAffiliation': 'Bina Nusantara University'}}}}