Interrelation of Diet, Gut Microbiome, and Autoantibody Production.
Ioanna Petta, Judith Fraussen, Veerle Somers...
https://pubmed.ncbi.nlm.nih.gov/29559977Actively Recruiting
Phase Not Applicable
Age: 12Years - 17Years
All Genders
Healthy Volunteers
ID05623007
Dietary Modulation of Gut Microbiota on Nutritional Status and COVID-19 Infection in Overweight and Obese Adolescents
Led by Indonesia University · Updated on 2025-02-25
440
Participants Needed
1
Research Sites
34 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
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
Brief Title
Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection
Who Can Participate
Age: 12Years - 17Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Living in Jakarta, Surabaya, or Yogyakarta for at least 6 months
- Generally healthy
- Male or female adolescents aged 12 to 17 years
- Overweight or obese with BMI-for-age z-score greater than +1SD
- Completed at least two doses of CoronaVac COVID-19 vaccine
- At least 6 months post vaccination before recruitment
- Parents willing to sign informed consent and adolescents provide assent
- Active health insurance coverage 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 or non-communicable diseases, congenital diseases, or disabilities
- Currently suspected or diagnosed active Tuberculosis
- History of gastrointestinal or malabsorption disorders within the last three months or during the study
- Antibiotic use within 2 weeks before the study start (can join after 3 weeks from last antibiotic)
- Use of medications or conditions that affect immune response, including immunodeficiency, immunosuppressants, blood transfusions
- Use of insulin or anti-dyslipidemia medications
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
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
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
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Research Team
R
Rina Agustina, PhD
R
Rahyussalim Rahyussalim, PhD
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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Published Research Related To This Trial
COVID-19 and Gut Microbiota: A Potential Connection.
Swati Rajput, Deepanshu Paliwal, Manisha Naithani...
https://pubmed.ncbi.nlm.nih.gov/33495676Randomized 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/22492764Gut Microbiota and Obesity: A Role for Probiotics.
Ludovico Abenavoli, Emidio Scarpellini, Carmela Colica...
https://pubmed.ncbi.nlm.nih.gov/31703257Study protocol for a randomised controlled trial evaluating the efficacy of dietary modulation of probiotics on nutritional status and antibody response to SARS-CoV-2 in Indonesian adolescents: gut-lung axis (DIVINE).
Rina Agustina, Karina R Ekawidyani, Mira Mutiyani...
https://pubmed.ncbi.nlm.nih.gov/40180370