Probiotics and Healthy Eating for Overweight Adolescents During COVID-19

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of probiotic supplementation and counseling on healthy eating and physical activity in overweight and obese adolescents aged 12-17 years who have received at least two doses of the CoronaVac® COVID-19 vaccine. The aim is to assess whether these interventions can improve gut microbiota, enhance immune response to SARS-CoV-2, and promote better health outcomes. Participants will be randomly assigned to receive either probiotics or placebo, alongside lifestyle counseling. The study is conducted in urban areas of Indonesia, focusing on the relationship between nutrition, infection, and immune health during adolescence.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
  Jakarta Pusat, DKI Jakarta, Indonesia Recruiting

Study contacts

• Principal investigator: Rina Agustina, PhD — Dep of Nutrition and Human Nutrition Research Center, IMERI, Fac of Medicine Universitas Indonesia
• Study coordinator: Rina Agustina, PhD
• Email: dr.rinaagustina@gmail.com
• Phone: +622129189160

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.