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

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.

Conditions

• Health Behavior
• Child Development
• Adolescent Obesity

Interventions

DIETARY_SUPPLEMENT

Probiotics

Combination of 3 probiotic strains: Lactobacillus rhamnosus (LGG), Bifidobacterium animalis subsp. lactis (BB-12), and Lactobacillus acidophilus (LA-5)

BEHAVIORAL

Counselling on healthy eating, physical activity, and psychosocial stimulation

Counselling on healthy eating, physical activity, and psychosocial stimulation.

DIETARY_SUPPLEMENT

Placebo probiotics

Maltodextrin

Sponsors & Collaborators

• Gadjah Mada University

  collaborator OTHER

• Universitas Airlangga

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• The Indonesia Endowment Funds for Education, Ministry of Finance Indonesia

  collaborator UNKNOWN

• Indonesia University

  lead OTHER

Principal Investigators

• Rina Agustina, PhD · Dep of Nutrition and Human Nutrition Research Center, IMERI, Fac of Medicine Universitas Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-01

Primary Completion

2025-04-30

Completion

2025-12-30

Countries

• Indonesia

Study Locations