Actively Recruiting
Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
Led by Indonesia University · Updated on 2025-02-25
440
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
I
Indonesia University
Lead Sponsor
G
Gadjah Mada University
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living in Jakarta, Surabaya, or Yogyakarta for at least 6 months permanently
- Apparently healthy
- Male or female aged 12 to 17 years
- Overweight or obese with BMI-for-age z-score greater than +1SD
- Completed at least two doses of the CoronaVac COVID-19 vaccine
- At least 6 months post COVID-19 vaccination prior to recruitment
- Parents willing to sign informed consent and adolescents provide assent
- Have active health insurance such as BPJS or similar
You will not qualify if you...
- History of COVID-19 infection within the last month confirmed by PCR or antigen test
- History of chronic, non-communicable, congenital diseases, or disabilities
- Currently diagnosed or suspected active Tuberculosis
- History of gastrointestinal or malabsorption disorders within last 3 months or during the study
- Taken antibiotics within 2 weeks before study start (eligible after 3 weeks since last antibiotic intake)
- Taking medications or having diseases that affect immune response (e.g., immune deficiencies, immunosuppressants, blood transfusions)
- Taking insulin or anti-dyslipidemia medications
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
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, 10430
Actively Recruiting
Research Team
R
Rina Agustina, PhD
CONTACT
R
Rahyussalim Rahyussalim, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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