NCT05623007 Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
| NCT ID | NCT05623007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indonesia University |
| Condition | Health Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2025-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2022-11-01 with a primary completion date of 2025-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Rina Agustina, PhD
PRINCIPAL INVESTIGATOR
Dep of Nutrition and Human Nutrition Research Center, IMERI, Fac of Medicine Universitas Indonesia
Frequently Asked Questions
Who can join the NCT05623007 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Health Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05623007 currently recruiting?
Yes, NCT05623007 is actively recruiting participants. Contact the research team at dr.rinaagustina@gmail.com for enrollment information.
Where is the NCT05623007 trial being conducted?
This trial is being conducted at Jakarta Pusat, Indonesia.
Who is sponsoring the NCT05623007 clinical trial?
NCT05623007 is sponsored by Indonesia University. The principal investigator is Rina Agustina, PhD at Dep of Nutrition and Human Nutrition Research Center, IMERI, Fac of Medicine Universitas Indonesia. The trial plans to enroll 440 participants.