Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection

Launched by INDONESIA UNIVERSITY · Nov 17, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a special type of supplement called probiotics, along with healthy eating and exercise, can help overweight and obese teenagers, particularly in relation to their immune response after getting the COVID-19 vaccine. Probiotics are good bacteria that can improve gut health, and the researchers want to see if they can help these adolescents not only manage their weight better but also boost their body's ability to fight infections like COVID-19.

To be eligible for this study, participants need to be between 12 and 17 years old, living in certain cities in Indonesia, and must be overweight or obese. They should have received at least two doses of the CoronaVac® COVID-19 vaccine and must be in good health overall. The study will involve a 20-week program where participants will receive guidance on diet, exercise, and use of probiotics. It's important for parents to know that their consent will be needed for their child to join, and participants will receive support throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. living in Jakarta, Surabaya, and Yogyakarta City for at least 6 months permanently;
• • 2. apparently healthy;
• • 3. male and female, age 12-17 years old;
• • 4. overweight or obese (BMI-for-age z-score \>+1SD);
• • 5. have completed at least two dosages of COVID-19 vaccine, the vaccine must be CoronaVac® (Sinovac);
• • 6. minimal 6 months post vaccinated prior to recruitments.
• • 7. parents willing to sign the informed consent and adolescents give informed assent;
• • 8. Must have an active health insurance, for instance BPJS or similar health insurance.
• Exclusion Criteria:
• • 1. having a history of COVID-19 infection within the last month confirmed by PCR or antigen from health care facilities or independent laboratory;
• • 2. having a history of chronic and non-communicable diseases, congenital diseases, and disabilities;
• • 3. reported current diagnosed as suspected active Tuberculosis (primary lung TB, miliary TB, bleeding cough bone TB, meningitis TB);
• • 4. 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;
• • 5. taking antibiotics during 2 weeks before the start of the study (adolescents will be included after 3 weeks of last antibiotic intake);
• • 6. taking other medications or having diseases that may influence the immune response - i.e. immune deficiencies, immunosuppressants medications, blood transfusion or other blood products;
• • 7. taking insulin and/or anti-dyslipidemia medication;
• • 8. being pregnant and/or breastfeeding.