Randomized trial of probiotics and calcium on diarrhea and respiratory tract infections in Indonesian children.
Rina Agustina, Frans J Kok, Ondine van de Rest...
https://pubmed.ncbi.nlm.nih.gov/22492764/Actively Recruiting
Led by Indonesia University · Updated on 2025-02-25
440
Participants Needed
1
Research Sites
34 weeks
Total Duration
Researchers are investigating how probiotic supplementation combined with counseling on healthy eating, physical activity, and psychosocial stimulation affects overweight and obese adolescents nutritional status and antibody response to COVID-19 vaccination. The study focuses on adolescents aged 12 to 17 years who have been vaccinated with CoronaVac and aims to understand the gut-lung-axis and the role of gut microbiota in immunity and infection risk, especially in the context of SARS-CoV-2. This randomized clinical trial is taking place in Indonesia, with attention to COVID-19 preventive measures during face-to-face activities. Participants are randomly assigned to one of two groups one receives a combination of three probiotic strains Lactobacillus rhamnosus, Bifidobacterium animalis subsp. lactis, and Lactobacillus acidophilus along with counseling, while the other receives placebo probiotics maltodextrin and the same counseling. The intervention lasts 20 weeks, with follow-up and assessment periods at 5, 10, 15, and 20 weeks to monitor changes. Counseling covers healthy eating, physical activity, and psychosocial stimulation to support overall health. During the study, researchers measure participants BMI-for-age z-scores and specific antibody levels against SARS-CoV-2 at multiple time points. They also analyze gut microbiota diversity, antibody affinity, secretory immunoglobulin A, and dietary quality. The study includes regular monitoring and assessments to evaluate the impact of the intervention on both nutritional and immune outcomes over the 20-week period.
CONDITIONS
Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
R
Rina Agustina, PhD
R
Rahyussalim Rahyussalim, PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Indonesia University
Lead Sponsor
Gadjah Mada University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 20 weeks
Participants receive either probiotics or placebo along with counselling on healthy eating, physical activity, and psychosocial stimulation.
Visits at Weeks 5, 10, 15, and 20 for assessments
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Rina Agustina, Frans J Kok, Ondine van de Rest...
https://pubmed.ncbi.nlm.nih.gov/22492764/Swati Rajput, Deepanshu Paliwal, Manisha Naithani...
https://pubmed.ncbi.nlm.nih.gov/33495676/Ludovico Abenavoli, Emidio Scarpellini, Carmela Colica...
https://pubmed.ncbi.nlm.nih.gov/31703257/Rina Agustina, Karina R Ekawidyani, Mira Mutiyani...
https://pubmed.ncbi.nlm.nih.gov/40180370/Ioanna Petta, Judith Fraussen, Veerle Somers...
https://pubmed.ncbi.nlm.nih.gov/29559977/Indonesia University
Lead Sponsor
Gadjah Mada University
Collaborating Sponsor