NCT05623007Recruiting
Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
Dietary Modulation of Gut Microbiota on Nutritional Status and COVID-19 Infection in Adolescents: Gut-Lung-Axis
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 31 Oct 2022
- Start date
- 1 Nov 2022
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Universitas Indonesia
- Diseases
- Obesity
- NCT number
- NCT05623007
What you commit to
- Study type: Interventional
- Planned participants: 440
- From 1 Nov 2022 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- taking antibiotics during 2 weeks before the start of the study (adolescents will be included after 3 weeks of last antibiotic intake);
- taking insulin and/or anti-dyslipidemia medication;
Other illness
- 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;
- taking other medications or having diseases that may influence the immune response - i.e. immune deficiencies, immunosuppressants medications, blood transfusion or other blood products;
Lab values
- having a history of COVID-19 infection within the last month confirmed by PCR or antigen from health care facilities or independent laboratory;
Other
- being pregnant and/or breastfeeding.
Who the study is looking for
- 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);
- have completed at least two dosages of COVID-19 vaccine, the vaccine must be CoronaVac® (Sinovac);
- minimal 6 months post vaccinated prior to recruitments.
- parents willing to sign the informed consent and adolescents give informed assent;
- Must have an active health insurance, for instance BPJS or similar health insurance.
Age in the registry: 12 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia Coordinator of this site? Confirm its status | Jakarta Pusat | Indonesia | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.