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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorIndonesia University

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

440 Participants
are divided into 2 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