Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05623007

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years

SexAll

Healthy volunteersAccepted

ConditionHealth Behavior, Child Development, Adolescent Obesity

Full registry 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.

Treatments and study arms

Probiotics

Dietary Supplement

Combination of 3 probiotic strains: Lactobacillus rhamnosus (LGG), Bifidobacterium animalis subsp. lactis (BB-12), and Lactobacillus acidophilus (LA-5)

Counselling on healthy eating, physical activity, and psychosocial stimulation

Behavioral

Counselling on healthy eating, physical activity, and psychosocial stimulation.

Placebo probiotics

Dietary Supplement

Maltodextrin

Primary outcomes

BMI-for-age z-scores (BAZ)5, 10, 15, and 20 weeks

Change in BAZ obtain from anthropometric measurements, i.e., weight (kg) and height (m) converted to BMI

Immunoglobulin G (IgG) specific to SARS-COV-2 titer concentrations10 and 20 weeks

Change in IgG specific to SARS-COV-2 titer concentrations assessed by electro chemiluminescence immunoassay (ECLIA)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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Rina Agustina, PhDContact

Email · Call +6221 2912477

Rina Agustina, PhDPrincipal Investigator

Julie Bines, PhDSub Investigator