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Effect of Probiotic Supplementation with Healthy Lifestyle Counseling on Gut Microbiota, Nutritional Status, and COVID-19 Immunity in Overweight and Obese Adolescents
Led by Indonesia University · Updated on 2025-02-25
440
Participants Needed
1
Research Sites
34 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how probiotic supplementation combined with counseling on healthy eating, physical activity, and psychosocial stimulation affects overweight and obese adolescents nutritional status and antibody response to COVID-19 vaccination. The study focuses on adolescents aged 12 to 17 years who have been vaccinated with CoronaVac and aims to understand the gut-lung-axis and the role of gut microbiota in immunity and infection risk, especially in the context of SARS-CoV-2. This randomized clinical trial is taking place in Indonesia, with attention to COVID-19 preventive measures during face-to-face activities. Participants are randomly assigned to one of two groups one receives a combination of three probiotic strains Lactobacillus rhamnosus, Bifidobacterium animalis subsp. lactis, and Lactobacillus acidophilus along with counseling, while the other receives placebo probiotics maltodextrin and the same counseling. The intervention lasts 20 weeks, with follow-up and assessment periods at 5, 10, 15, and 20 weeks to monitor changes. Counseling covers healthy eating, physical activity, and psychosocial stimulation to support overall health. During the study, researchers measure participants BMI-for-age z-scores and specific antibody levels against SARS-CoV-2 at multiple time points. They also analyze gut microbiota diversity, antibody affinity, secretory immunoglobulin A, and dietary quality. The study includes regular monitoring and assessments to evaluate the impact of the intervention on both nutritional and immune outcomes over the 20-week period.
CONDITIONS
Brief Title
Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
Research Team
R
Rina Agustina, PhD
R
Rahyussalim Rahyussalim, PhD
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