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Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection

Study acronym: DIVINE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 25, 2025 (before its estimated April 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Site contact updatedv3
  3. Phase: Phase 2 to Not applicable
    • Primary completion date: Apr 30, 2024 to Apr 30, 2025
    • Study completion date: Nov 2, 2025 to Dec 30, 2025
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Universitas Indonesia
94 trials monitored
See 3 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
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.
Trial Details
NCT Number NCT05623007
Lead Sponsor Universitas Indonesia
Collaborators: Gadjah Mada University, Universitas Airlangga, University of Melbourne, The Indonesia Endowment Funds for Education, Ministry of Finance Indonesia
Conditions
(from sponsor)		 Health Behavior, Child Development, Adolescent Obesity
Related terms COVID-19, Health Behavior, Obesity, Overweight, Pediatric Obesity
Enrollment 440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov