Probiotics and Healthy Eating for Overweight Adolescents During COVID-19

Dietary Modulation of Gut Microbiota on Nutritional Status and COVID-19 Infection in Adolescents: Gut-Lung-Axis

This study is testing if giving probiotics and healthy eating advice can help overweight teens who have had the COVID-19 vaccine feel better and improve their health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 440 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Indonesia University (other)
• Locations: 1 site (Jakarta Pusat, DKI Jakarta)
• Trial ID: NCT05623007 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are healthy adolescents aged 12-17 years, living in Jakarta, Surabaya, or Yogyakarta, who are overweight or obese and have completed at least two doses of the CoronaVac® vaccine.

Not a fit: Patients with a recent history of COVID-19 infection, chronic diseases, or gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel approach to improving health and immune response in overweight adolescents, potentially reducing their risk of severe COVID-19 outcomes.

How similar studies have performed: While there is limited evidence specifically addressing probiotics in this context, previous studies have shown potential benefits of probiotics in improving health outcomes in overweight adolescents.

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.

Where this trial is running

Jakarta Pusat, DKI Jakarta

• 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

Conditions: Health Behavior, Child Development, Adolescent Obesity, adolescent, probiotics, COVID-19, overweight, obese