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Official title Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
ClinicalTrials.gov ID: NCT05623007
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 17. Healthy volunteers may be eligible.
You may be able to join if
- 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);
You likely can't join if
- 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...
- taking antibiotics during 2 weeks before the start of the study (adolescents will be included after 3 weeks of last antibiotic intake);
- taking other medications or having diseases that may influence the immune response - i.e. immune deficiencies, immunosuppressants medications, blood...
See the full eligibility criteria
- 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.
- 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;
- taking antibiotics during 2 weeks before the start of the study (adolescents will be included after 3 weeks of last antibiotic intake);
- taking other medications or having diseases that may influence the immune response - i.e. immune deficiencies, immunosuppressants medications, blood transfusion or other blood products;
- taking insulin and/or anti-dyslipidemia medication;
- being pregnant and/or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Jakarta Pusat, DKI Jakarta, Indonesia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jakarta Pusat, DKI Jakarta, Indonesia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.