An interventional study of Probiotics and Counselling on healthy eating, physical activity, and psychosocial stimulation in Health Behavior, Child Development and Adolescent Obesity, sponsored by Universitas Indonesia. Recruiting at 1 site in Indonesia. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Universitas Indonesia · Not applicable, Interventional, and Prevention
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.
The adolescence period is the transition from childhood to adulthood. Adolescents are vulnerable to many biomedical exposures, such as a low-quality diet, fewer fruits and vegetable intake, low physical activities, smoking habits, and alcohol consumption; and non-biomedical aspects such as mental depression, parental distress, and household income, which were known to be associated with increased risk of many health outcomes. Obese adolescents are vulnerable to many infections, poor disease outcomes and complications, and lower antibody response to vaccinations. Studies that have investigated Covid-19 incidence in overweight and obese individuals are still scarce. Adolescence is also a sensitive period to microbial change or dysbiosis due to practicing poor diet, low physical activity, inadequate sleep, stress, and substance use (smoking, drugs, and alcohol). Despite the existing prevalence of SARS-COV-2 infections is increasing in adolescents, and the vaccine program is not prioritized in this population, making the prevention strategy for SARS-COV-2 infection may become less effective in this population. Besides, low-quality diet and lifestyle habits and family cluster transmission at home are often not fully addressed in the policy. These factors may be the contributors to the potential highest COVID-19 exposure for children and adolescents. Since exposure among adolescents is linked to serious adverse health effects, effective interventions to improve nutritional outcomes and reduce the risk of COVID-19 infection will provide substantial long-term returns. However, such interventions for adolescents in Indonesia and globally are lacking.
This study is a randomized clinical trial (RCT) and placebo parallel controlled study. The research will be conducted in junior and senior high schools in Jakarta, Surabaya, and Yogyakarta, Indonesia.
In light of COVID-19 outbreak, if face-to-face activities are permitted by (1) national government (Indonesian Ministry of Health), (2) local government (DKI Jakarta), (3) the university, (4) Data Safety Monitoring Board, and (5) by consent of the subject, then the activities need to be strictly adjusted with the COVID-19 prevention measures for both personnel and subjects. All personnel and subjects who will be involved in the activities are required to fill out the COVID-19 symptom screening form prior to the visit and have been vaccinated with a complete dose.
249 studies on the registry are indexed under Health Behavior; 98 are open to participants now.
This study's planned enrollment of 440 is above the median of 120 across 213 interventional studies indexed under Health Behavior.
Browse Health Behavior studies →Universitas Indonesia is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
220 overweight/obese adolescents will be given Probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.
Dietary Supplement: Probiotics · Behavioral: Counselling on healthy eating, physical activity, and psychosocial stimulation
220 overweight/obese adolescents will be given placebo probiotics and counselling on healthy eating, physical activity, and psychosocial stimulation.
Behavioral: Counselling on healthy eating, physical activity, and psychosocial stimulation · Dietary Supplement: Placebo probiotics
Combination of 3 probiotic strains: Lactobacillus rhamnosus (LGG), Bifidobacterium animalis subsp. lactis (BB-12), and Lactobacillus acidophilus (LA-5)
Counselling on healthy eating, physical activity, and psychosocial stimulation.
Maltodextrin
BMI-for-age z-scores (BAZ)
Change in BAZ obtain from anthropometric measurements, i.e., weight (kg) and height (m) converted to BMI
Time frame: 5, 10, 15, and 20 weeks
Immunoglobulin G (IgG) specific to SARS-COV-2 titer concentrations
Change in IgG specific to SARS-COV-2 titer concentrations assessed by electro chemiluminescence immunoassay (ECLIA)
Time frame: 10 and 20 weeks
α-gut microbiota diversity
Change in α-diversity measured by 1) Chao1, 2) phylogenetic diversity, and 3) the Shannon index.
Time frame: 20 weeks
β-gut microbiota diversity
Change in β -diversity: as the variability in community composition (the identity of taxa observed) among samples
Time frame: 20 weeks
Monoclonal antibody affinity against SARS-COV-2
Change in equilibrium dissociation constant (KD) of monoclonal antibody against SARS-COV-2 spike protein measured by competitive ELISA
Time frame: 10 and 20 weeks
Secretory Immunoglobulin A (sIgA) specific to SARS-COV-2 titer concentrations
Change in sIgA specific to SARS-COV-2 titer concentrations assessed by competitive ELISA
Time frame: 10 and 20 weeks
Dietary quality
Change in score of dietary quality assessed by Healthy Eating Index 2015 from 24 hour recalls data
Time frame: 5, 10, 15, and 20 weeks
SARS-COV-2 infection
Changes in proportion of symptomatic COVID-19 and positive PCR
Time frame: 20 weeks
Body height
Changes in height-for-age z-score by anthropometric measurement
Time frame: 5, 10, 15, and 20 weeks
Abdominal obesity (waist circumference)
Changes in waist circumference by anthropometric measurement
Time frame: 5, 10, 15, and 20 weeks
Abdominal obesity (waist-hip ratio)
Changes in waist-hip ratio by anthropometric measurement
Time frame: 5, 10, 15, and 20 weeks
Middle upper arm circumference
Changes in middle upper arm circumference by anthropometric measurement
Time frame: 5, 10, 15, and 20 weeks
Immunoglobulin M (IgM) against SARS-Cov-2
Changes in IgM titer concentrations assessed by electro chemiluminescence immunoassay (ECLIA)
Time frame: 10 and 20 weeks
Neutralizing antibody against SARS-Cov-2
Changes in total neutralizing antibody titer assessed by Surrogate Virus Neutralization Test (sVNT)
Time frame: 10 and 20 weeks
Gut integrity (zonulin)
Changes in the level of serum zonulin assessed by ELISA and Changes in the level of fecal zonulin assessed by ELISA
Time frame: 20 weeks
Gut integrity (occludin)
Changes in the level of fecal occludin assessed by ELISA
Time frame: 20 weeks
Gut inflammation
Changes in concentration of fecal calprotectin assessed by ELISA
Time frame: 20 weeks
Gut microbiota profiling
Changes in composition of gut microbiota assessed by next-generation sequencing (NGS)
Time frame: 20 weeks
Short Chain Fatty Acids (SCFA)
Change in concentration of the SCFA by gas chromatograph
Time frame: 20 weeks
Physical activity
Changes in International Physical Activity Questionnaire for Adolescent (IPAQ-A) score, the minimum is 0 metabolic equivalents of task (MET) minutes/week, and the maximum score is 3000 MET minutes/week. Higher score means better outcome.
Time frame: 5, 10, 15, and 20 weeks
Body image
Changes in Body Shape Questionnaire-34 (BSQ-34) score. The minimum score is 34, and the maximum is 204. Higher score means worse outcome
Time frame: 20 weeks
Depression
Changes in Patient Health Questionnaire for Adolescents (PHQ-A) score. The minimum score is 0, and the maximum is 27. Higher scores mean worse outcome.
Time frame: 20 weeks
Self-esteem
Changes in Rosenberg Self Esteem Scale. The minimum score is 0, and the maximum score is 37. Higher scores mean better outcome.
Time frame: 20 weeks
Quality of life score
Changes in the score of Youth Quality of Life for adolescents-Research version (YQOL-R). The minimum score is 0, and the maximum score is 100. Higher scores mean better outcome.
Time frame: 20 weeks
Morbidity
Type and frequency of illness
Time frame: 5, 10, 15, and 20 weeks
Mortality
Type and frequency of illness
Time frame: 5, 10, 15, and 20 weeks
Wechsler Intelligence Scale for Children score
Changes in Wechsler Intelligence Scale for Children (WISC). The minimum score is 70, and the maximum score is 159. Higher scores mean better outcome.
Time frame: 20 weeks
Brain Derived Neurotropic Factor level
Changes in level of Brain Derived Neurotropic Factor (BDNF) assessed by ELISA
Time frame: 20 weeks
Anemia status
Changes in hemoglobin concentration
Time frame: 20 weeks
Plan to share: No — We will make data from the clinical trials available upon reasonable request subject to approval from the Ministry of Health of the Republic of Indonesia. This will be in accordance with the following regulations: (1) Regulation of the Ministry of Health No. 85 Year 2020 concerning the Transfer and Use of Materials, Information Content, and Data; (2) Law No. 17 Year 2023 on Health; (3) Government Regulation No. 28 Year 2024 on the Implementation Regulation of Law No. 17 of 2023 on Health; (4) Law No. 27 of 2022 on Personal Data Protection. The individual data will be kept anonymous.
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