Dietary Modulation of Gut Microbiota on Nutritional Status and COVID-19 Infection in Adolescents: Gut-Lung-Axis

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Indonesia
Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia
RECRUITING
Jakarta Pusat
Contact Information
Primary
Rina Agustina, PhD
dr.rinaagustina@gmail.com
+622129189160
Backup
Rahyussalim Rahyussalim, PhD
manajer.riset.fkui1@gmail.com
+622129189160
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 440
Treatments
Experimental: Intervention
220 overweight/obese adolescents will be given Probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.
Placebo_comparator: Control
220 overweight/obese adolescents will be given placebo probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.
Sponsors
Collaborators: Gadjah Mada University, Universitas Airlangga, The Indonesia Endowment Funds for Education, Ministry of Finance Indonesia, University of Melbourne
Leads: Indonesia University

This content was sourced from clinicaltrials.gov