Evidence map›Paper›PMID 40180370›Full record

ArticleBMJ open2025

Study 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, Erfi Prafiantini, Triska S Nindya, Wahyu Damayanti, Purwo S Rejeki, Lilik Djuari, Emy Huriyati, Julie E Bines and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05623007 (Dietary Modulation of Gut Microbiota on Nutritional Status and COVID-19 Infection in Adolescents), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05623007 narecruitingnot on this map

Dietary Modulation of Gut Microbiota on Nutritional Status and COVID-19 Infection in Adolescents: Gut-Lung-Axis

TypeinterventionalSponsorIndonesia UniversityRan2022 to 2025Enrolled440ConditionsHealth Behavior, Child Development, Adolescent ObesityArmsProbiotics, Counselling on healthy eating, physical activity, and psychosocial stimulation, Placebo probiotics
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Rina AgustinaDepartment of Nutrition, Faculty of Medicine - Dr. Cipto Mangunkusumo General Hospital, Universitas Indonesia, Jakarta, Indonesia r.agustina@ui.ac.id dr.rinaagustina@gmail.com.ORCID http://orcid.org/0000-0002-8464-1037
Karina R EkawidyaniDoctoral Study Program in Nutrition, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.ORCID http://orcid.org/0000-0002-5414-5040
Mira MutiyaniDoctoral Study Program in Nutrition, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.ORCID http://orcid.org/0000-0002-0072-6384
Erfi PrafiantiniDepartment of Nutrition, Faculty of Medicine - Dr. Cipto Mangunkusumo General Hospital, Universitas Indonesia, Jakarta, Indonesia.
Triska S NindyaDoctoral Study Program in Nutrition, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Wahyu DamayantiDepartment of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.
Purwo S RejekiPhysiology Division, Department of Medical Physiology and Biochemistry, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, Indonesia.
Lilik DjuariDepartment of Public Health and Preventive Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, East Java, Indonesia.
Emy HuriyatiDepartment of Nutrition and Health, Faculty of Medicine, Public Health and Nursing, Gadjah Mada University, Yogyakarta, Indonesia.
Julie E BinesDepartment of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia.
Muhammad JuffrieDepartment of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDuring the pandemic, overweight and obese adolescents were at a higher risk of COVID-19 infection. Indonesia's government has implemented prevention programmes and immunisation; however, the rise in SARS-CoV-2 infections among adolescents is exacerbated by low-quality diet and lifestyle habits. Also, the vaccine programme is not prioritised in this population. To address this, a solution involves providing probiotics and counselling on healthy lifestyle habits to improve diet and immunity. Therefore, we designed a protocol for a randomised controlled trial with a 20-week intervention to investigate the effect of probiotics supplementation and counselling on healthy lifestyle habits, including healthy eating and physical activity, and psychosocial stimulation, on nutritional status and antibody response against SARS-CoV-2 in this group. METHODS AND ANALYSIS: This clinical trial aims to investigate the effects of probiotic supplementation on healthy overweight and obese adolescents. The study will involve 440 adolescents aged 12-17 living in Jakarta, Surabaya or Yogyakarta for at least 6 months and have completed at least two doses of the COVID-19 vaccine. The intervention group will receive daily probiotic supplementation of three strains, including ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Faculty of Medicine, Universitas Indonesia-Cipto Mangunkusumo Hospital (KET 763/UN2.F1/ETIK/PPM.00.02/2022: 1 August 2022). The study results will be disseminated in open-access international journals, scientific meetings and conferences with stakeholders. TRIAL REGISTRATION NUMBER: The study has been registered at https://clinicaltrials.gov with identifier number NCT05623007.

Indexed as

COVID-19Nutritional StatusPediatric ObesityProbioticsAdolescentAntibody FormationChildFemaleGastrointestinal MicrobiomeHumansIndonesiaMaleOverweightRandomized Controlled Trials as TopicSARS-CoV-2AdolescentObesityOverweightProbioticRandomized Controlled TrialSARS-CoV-2 Infection

Identifiers

PMID40180370
PMCPMC11969610

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.