{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T20:21:12Z","timestamp":1785356472443,"version":"3.55.0"},"reference-count":65,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2025,4,2]],"date-time":"2025-04-02T00:00:00Z","timestamp":1743552000000},"content-version":"unspecified","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,2,28]]},"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>During the pandemic, overweight and obese adolescents were at a higher risk of COVID-19 infection. Indonesia\u2019s government has implemented prevention programmes and immunisation; however, the rise in SARS-CoV-2 infections among adolescents is exacerbated by low-quality diet and lifestyle habits. Also, the vaccine programme is not prioritised in this population. To address this, a solution involves providing probiotics and counselling on healthy lifestyle habits to improve diet and immunity. Therefore, we designed a protocol for a randomised controlled trial with a 20-week intervention to investigate the effect of probiotics supplementation and counselling on healthy lifestyle habits, including healthy eating and physical activity, and psychosocial stimulation, on nutritional status and antibody response against SARS-CoV-2 in this group.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      This clinical trial aims to investigate the effects of probiotic supplementation on healthy overweight and obese adolescents. The study will involve 440 adolescents aged 12\u201317 living in Jakarta, Surabaya or Yogyakarta for at least 6 months and have completed at least two doses of the COVID-19 vaccine. The intervention group will receive daily probiotic supplementation of three strains, including\n                      <jats:italic>Bifidobacterium animalis<\/jats:italic>\n                      subsp.\n                      <jats:italic>Lactis<\/jats:italic>\n                      (BB-12),\n                      <jats:italic>Lactobacillus acidophilus<\/jats:italic>\n                      (LA-5) and\n                      <jats:italic>Lactobacillus rhamnosus<\/jats:italic>\n                      (LGG), at the level of 10\n                      <jats:sup>9<\/jats:sup>\n                      \u201310\n                      <jats:sup>10<\/jats:sup>\n                      colony-forming units for 20\u2009weeks, while the control group will receive a placebo. Both groups will receive weekly counselling on healthy eating habits, physical activity and psychosocial stimulation. The primary outcomes will be changes in the body mass index for age z-score and IgG specific to SARS-CoV-2 titre concentrations between groups. The secondary outcomes will include changes in secretory IgA specific to SARS-CoV-2 titre concentrations, monoclonal antibodies against SARS-CoV-2 spike protein, gut microbiota diversity and the score of Healthy Eating Index 2015.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study protocol was approved by the Ethics Committee of the Faculty of Medicine, Universitas Indonesia-Cipto Mangunkusumo Hospital (KET 763\/UN2.F1\/ETIK\/PPM.00.02\/2022: 1 August 2022). The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      The study has been registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\">https:\/\/clinicaltrials.gov<\/jats:ext-link>\n                      with identifier number\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05623007\">NCT05623007<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-087934","type":"journal-article","created":{"date-parts":[[2025,4,3]],"date-time":"2025-04-03T02:25:14Z","timestamp":1743647114000},"page":"e087934","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Study protocol for a randomised controlled trial evaluating the efficacy of dietary modulation of probiotics on nutritional status and antibody response to SARS-CoV-2 in Indonesian adolescents: gut-lung axis (DIVINE)"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct05623007","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8464-1037","authenticated-orcid":false,"given":"Rina","family":"Agustina","sequence":"first","affiliation":[{"name":"Department of Nutrition, Faculty of Medicine - 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Dr. Cipto Mangunkusumo General Hospital, Universitas Indonesia, Jakarta, Indonesia"},{"name":"Human Nutrition Research Center, Indonesian Medical Education and Research Institute (HNRC-IMERI), Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Triska S.","family":"Nindya","sequence":"additional","affiliation":[{"name":"Doctoral Study Program in Nutrition, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia"},{"name":"Department of Nutrition, Faculty of Public Health, Universitas Airlangga, Surabaya, East Java, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wahyu","family":"Damayanti","sequence":"additional","affiliation":[{"name":"Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Purwo S.","family":"Rejeki","sequence":"additional","affiliation":[{"name":"Physiology Division, Department of Medical Physiology and Biochemistry, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lilik","family":"Djuari","sequence":"additional","affiliation":[{"name":"Department of Public Health and Preventive Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emy","family":"Huriyati","sequence":"additional","affiliation":[{"name":"Department of Nutrition and Health, Faculty of Medicine, Public Health and Nursing, Gadjah Mada University, Yogyakarta, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie E.","family":"Bines","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Gastroenterology and Clinical Nutrition, Royal Children\u2019s Hospital Research Institute, Parkville, Victoria, Australia"},{"name":"Murdoch Children\u2019s Research Institute, Parkville, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad","family":"Juffrie","sequence":"additional","affiliation":[{"name":"Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,4,2]]},"reference":[{"key":"2025121510491574000_15.4.e087934.1","unstructured":"Pandemic C-C . 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