About this trial
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.
Eligibility criteria
Qualifiers
living in Jakarta, Surabaya, and Yogyakarta City for at least 6 months permanently;
apparently healthy;
male and female, age 12-17 years old;
overweight or obese (BMI-for-age z-score >+1SD);
Disqualifiers
having a history of COVID-19 infection within the last month confirmed by PCR or antigen from health care facilities or independent laboratory;
having a history of chronic and non-communicable diseases, congenital diseases, and disabilities;
reported current diagnosed as suspected active Tuberculosis (primary lung TB, miliary TB, bleeding cough bone TB, meningitis TB);
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;
Trial design
Treatments tested in this trial
- Probiotics
- Counselling on healthy eating, physical activity, and psychosocial stimulation
- Placebo probiotics
Treatment groups
Sponsors and collaborators
Indonesia University
Lead sponsor
Gadjah Mada University
Collaborator
Universitas Airlangga
Collaborator
University of Melbourne
Collaborator
The Indonesia Endowment Funds for Education, Ministry of Finance Indonesia
Collaborator