[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487125":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":112,"collaborators":115,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":27,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","220 overweight\u002Fobese adolescents will be given Probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.",[13,14],"Dietary Supplement: Probiotics","Behavioral: Counselling on healthy eating, physical activity, and psychosocial stimulation",{"label":16,"type":17,"description":18,"interventionNames":19},"Control","PLACEBO_COMPARATOR","220 overweight\u002Fobese adolescents will be given placebo probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.",[14,20],"Dietary Supplement: Placebo probiotics",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIETARY_SUPPLEMENT","Probiotics","Combination of 3 probiotic strains: Lactobacillus rhamnosus (LGG), Bifidobacterium animalis subsp. lactis (BB-12), and Lactobacillus acidophilus (LA-5)",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"BEHAVIORAL","Counselling on healthy eating, physical activity, and psychosocial stimulation","Counselling on healthy eating, physical activity, and psychosocial stimulation.",[16,9],{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Placebo probiotics","Maltodextrin",[16],[38],{"name":39,"affiliation":40,"role":41},"Rina Agustina, PhD","Dep of Nutrition and Human Nutrition Research Center, IMERI, Fac of Medicine Universitas Indonesia","PRINCIPAL_INVESTIGATOR",[43,48],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","+622129189160","201052","dr.rinaagustina@gmail.com",{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},"Rahyussalim Rahyussalim, PhD","201908","manajer.riset.fkui1@gmail.com",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia","RECRUITING","Jakarta Pusat","DKI Jakarta","10430","Indonesia","ID",{"type":62,"coordinates":63},"Point",[64,65],106.8223,-6.1818,{"lat":65,"lon":64},[68,70,71,74,76,78,80,82,84,86,88,90,92,94,96,98,100,102,104,106,108,110],{"name":39,"role":44,"phone":69,"phoneExt":27,"email":47},"+6221 2912477",{"name":39,"role":41,"phone":27,"phoneExt":27,"email":27},{"name":72,"role":73,"phone":27,"phoneExt":27,"email":27},"Julie Bines, PhD","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":27,"phoneExt":27,"email":27},"Susan Sawyer, PhD",{"name":77,"role":73,"phone":27,"phoneExt":27,"email":27},"Murdani Abdullah, PhD",{"name":79,"role":73,"phone":27,"phoneExt":27,"email":27},"Erfi Prafiantini, MSc",{"name":81,"role":73,"phone":27,"phoneExt":27,"email":27},"Dwiana Ocviyanti, PhD",{"name":83,"role":73,"phone":27,"phoneExt":27,"email":27},"Karina R Ekawidyani, PhD",{"name":85,"role":73,"phone":27,"phoneExt":27,"email":27},"Dian N Chandra, PhD",{"name":87,"role":73,"phone":27,"phoneExt":27,"email":27},"Mira Mutiyani, MSc",{"name":89,"role":73,"phone":27,"phoneExt":27,"email":27},"Alfi R Putri, MSc",{"name":91,"role":73,"phone":27,"phoneExt":27,"email":27},"Triska S Nindya, PhD",{"name":93,"role":73,"phone":27,"phoneExt":27,"email":27},"Mohammad Juffrie, PhD",{"name":95,"role":73,"phone":27,"phoneExt":27,"email":27},"Emy Huriyati, PhD",{"name":97,"role":73,"phone":27,"phoneExt":27,"email":27},"Wahyu Damayanti, MSc",{"name":99,"role":73,"phone":27,"phoneExt":27,"email":27},"Ainun Nisa, SGz",{"name":101,"role":73,"phone":27,"phoneExt":27,"email":27},"Purwo S Rejeki, PhD",{"name":103,"role":73,"phone":27,"phoneExt":27,"email":27},"Lilik Djuari, PhD",{"name":105,"role":73,"phone":27,"phoneExt":27,"email":27},"Dwi Susanti, PhD",{"name":107,"role":73,"phone":27,"phoneExt":27,"email":27},"Adi Pranoto, MKes",{"name":109,"role":73,"phone":27,"phoneExt":27,"email":27},"Fhadilla Amelia, MSc",{"name":111,"role":73,"phone":27,"phoneExt":27,"email":27},"Alpha F Athiyyah, PhD",{"type":41,"investigatorFullName":113,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Prof Rina Agustina, MD, PhD","Principal Investigator",[116,118,120,122],{"name":117,"class":6},"Gadjah Mada University",{"name":119,"class":6},"Universitas Airlangga",{"name":121,"class":6},"University of Melbourne",{"name":123,"class":124},"The Indonesia Endowment Funds for Education, Ministry of Finance Indonesia","UNKNOWN","100487125","dietary-modulation-of-gut-microbiota-in-overweightobese-adolescents-and-covid-19-infection-100487125",false,"NCT05623007","Dietary Modulation of Gut Microbiota in Overweight\u002FObese Adolescents and COVID-19 Infection","Dietary Modulation of Gut Microbiota on Nutritional Status and COVID-19 Infection in Adolescents: Gut-Lung-Axis","DIVINE","Inclusion Criteria:\n\n1. living in Jakarta, Surabaya, and Yogyakarta City for at least 6 months permanently;\n2. apparently healthy;\n3. male and female, age 12-17 years old;\n4. overweight or obese (BMI-for-age z-score \\>+1SD);\n5. have completed at least two dosages of COVID-19 vaccine, the vaccine must be CoronaVac® (Sinovac);\n6. minimal 6 months post vaccinated prior to recruitments.\n7. parents willing to sign the informed consent and adolescents give informed assent;\n8. Must have an active health insurance, for instance BPJS or similar health insurance.\n\nExclusion Criteria:\n\n1. having a history of COVID-19 infection within the last month confirmed by PCR or antigen from health care facilities or independent laboratory;\n2. having a history of chronic and non-communicable diseases, congenital diseases, and disabilities;\n3. reported current diagnosed as suspected active Tuberculosis (primary lung TB, miliary TB, bleeding cough bone TB, meningitis TB);\n4. having a history of gastrointestinal or malabsorption disorder (such as celiac disease and inflammatory bowel disease) within the last three months or during the study;\n5. taking antibiotics during 2 weeks before the start of the study (adolescents will be included after 3 weeks of last antibiotic intake);\n6. taking other medications or having diseases that may influence the immune response - i.e. immune deficiencies, immunosuppressants medications, blood transfusion or other blood products;\n7. taking insulin and\u002For anti-dyslipidemia medication;\n8. being pregnant and\u002For breastfeeding.",true,"ALL","12 Years","17 Years",{"count":138,"type":139},440,"ESTIMATED","INTERVENTIONAL",[142],"NA","Probiotic intervention has been currently suggested to provide supportive benefits in promoting health, including alleviating disease symptoms, protecting against diarrhea and respiratory infection, affecting growth and modulating the immune system by improving the beneficial gut microbiota colonization, giving direction on the gut-lung-axis pathway. This indicates that probiotics may become alternative to improve nutrition and reduce the risk of viral infections which may reduce the risk against Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2). Introduction to probiotics during adolescence can alleviate inflammation and invert dysbiosis. However, evidence on the effect of probiotic supplementation on enhancing antibody response to SARS COV-2 in adolescents is lacking. Moreover, previous studies showed the potential effect of probiotic supplementation to improve overweight and obesity in adolescents. A bi-directional relationship exists among nutrition, infection, and immunity as changes in one element will affect the others. The main objective of this study is to investigate the effect of dietary modulation of overweight and obese adolescent's gut microbiota through probiotic supplementation combined with healthy eating and physical activity counseling and psychosocial stimulation on nutritional status and antibody response to COVID-19 vaccination. This trial will conduct a 20-week intervention for overweight and obese adolescents.",[145,146,147],"Health Behavior","Child Development","Adolescent Obesity",[149,150,151,152,153],"adolescent","probiotics","COVID-19","overweight","obese","2025-02-23",{"date":156,"type":157},"2025-02-25","ACTUAL",{"date":159,"type":157},"2022-11-01",{"date":161,"type":139},"2025-12-30",{"name":5,"class":6},1]