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AzTrials

Obesity, ChildhoodNCT03388411

Nutritional Intake and Gut Microbiome

An observational study of Obesity, Childhood, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pediatric obesity has been increasing in prevalence, but concerns have been raised around the world because no treatment has been found. Recently, however, research on gut microbiome has begun to become a new alternative. It has been shown that changes in the microbiome in adults may induce obesity. Read more about this study

Who is it for?
Ages Up to 12 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood
What is being tested?
Gut microbiome profiling
How many people
61 participants
Where
1 siteSouth Korea
Study dates
18 Oct 2017to 12 Oct 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Primary care clinic and community samples

Who may be able to join

  • Obese children: Children ≥95 ‰ between age 7 and 12 years
  • Non-obese children: 5‰<BMI <85 ‰ for children between the ages of 7 and 12 years

Who cannot join

  • Taking antibiotics, probiotics, or steroids for a month before visit
  • Taking probiotics-like products including yogurt for seven days before visit
  • Having enteritis symptoms including diarrhea for a month before visit
  • Chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney disease, endocrine disease, genetic diseases or congenital metabolic disorder

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07440

Other trials in South Korea

About this study

Official title: Nutritional Intake, Metabolic Abnormalities and Gut Microbiome in Children

Pediatric obesity has been increasing in prevalence, but concerns have been raised around the world because no treatment has been found. Recently, however, research on gut microbiome has begun to become a new alternative. It has been shown that changes in the microbiome in adults may induce obesity. However, the results on children are still scarce. Unlike adults, children have few external factors such as alcohol, tobacco, stress, and cancer, making them suitable for obesity-related gut microbiome studies. The investigators will use Illumina MiSeq platform for 16s rRNA metagenomics profiling in children. In this study, the investigators aimed to analyze the relationship between pediatric obesity, gut microbiome profile, blood biomarkers relevant to metabolic syndrome, and nutrient intake data.

Being tested
Gut microbiome profiling
Keywords
Microbiome, Gut
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gut microbiome profilingDiagnostic test

    Also called 16s metagenomic analysis

    Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.

Study groups in NCT03388411
Study groupRoleWhat they receive
Obese childrenChildren ≥95 ‰ between age 7 and 12 years
Receives: Diagnostic Test: Gut microbiome profiling
Non-obese children5‰< BMI <85 ‰ for children between the ages of 7 and 12 years
Receives: Diagnostic Test: Gut microbiome profiling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of fecal microbial profile with childhood obesity

    Analysis of fecal microbial profile using 16s rRNA sequencing

    Measured: visit 1day

  2. Correlation of fecal microbial profile with nutrient intake data using feeding diary

    Nutritional intake analysis of total calorie, carbohydrate, fiber, fat, and protein from feeding dairy for two days

    Measured: visit 1day

Secondary outcomes (1)

  1. Correlation of childhood obesity with metabolic abnomalities using blood sampling

    Glucose, AST, ALT, uric acid, triglyceride, HDL-cholesterol, LDL-cholesterol, total cholesterol, insulin, hsCRP, 25(OH)-Vitamin D3, hemoglobin, ferritin, and HbA1c

    Measured: visit 1day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2018
  2. Study start18 Oct 2017
  3. Primary completion12 Oct 2018
  4. Study completion12 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03388411
Sponsor's protocol ID
Gut microbiome
Status last verified
Feb 2019
First submitted
19 Dec 2017
Last updated
27 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study participants will only agree if IPD is not shared.

Publications

  • Clemente JC, Ursell LK, Parfrey LW, Knight R. The impact of the gut microbiota on human health: an integrative view. Cell. 2012 Mar 16;148(6):1258-70. doi: 10.1016/j.cell.2012.01.035.

    PubMed 22424233

  • Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Dore J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium; Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.

    PubMed 20203603

  • Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, Gill SR, Nelson KE, Relman DA. Diversity of the human intestinal microbial flora. Science. 2005 Jun 10;308(5728):1635-8. doi: 10.1126/science.1110591. Epub 2005 Apr 14.

    PubMed 15831718

  • Yun Y, Kim HN, Kim SE, Heo SG, Chang Y, Ryu S, Shin H, Kim HL. Comparative analysis of gut microbiota associated with body mass index in a large Korean cohort. BMC Microbiol. 2017 Jul 4;17(1):151. doi: 10.1186/s12866-017-1052-0.

    PubMed 28676106

  • David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.

    PubMed 24336217

  • Hu HJ, Park SG, Jang HB, Choi MK, Park KH, Kang JH, Park SI, Lee HJ, Cho SH. Obesity Alters the Microbial Community Profile in Korean Adolescents. PLoS One. 2015 Jul 31;10(7):e0134333. doi: 10.1371/journal.pone.0134333. eCollection 2015.

    PubMed 26230509

  • Cox AJ, West NP, Cripps AW. Obesity, inflammation, and the gut microbiota. Lancet Diabetes Endocrinol. 2015 Mar;3(3):207-15. doi: 10.1016/S2213-8587(14)70134-2. Epub 2014 Jul 22.

    PubMed 25066177

  • Schwiertz A, Taras D, Schafer K, Beijer S, Bos NA, Donus C, Hardt PD. Microbiota and SCFA in lean and overweight healthy subjects. Obesity (Silver Spring). 2010 Jan;18(1):190-5. doi: 10.1038/oby.2009.167. Epub 2009 Jun 4.

    PubMed 19498350

  • Turnbaugh PJ, Backhed F, Fulton L, Gordon JI. Diet-induced obesity is linked to marked but reversible alterations in the mouse distal gut microbiome. Cell Host Microbe. 2008 Apr 17;3(4):213-23. doi: 10.1016/j.chom.2008.02.015.

    PubMed 18407065

  • Jumpertz R, Le DS, Turnbaugh PJ, Trinidad C, Bogardus C, Gordon JI, Krakoff J. Energy-balance studies reveal associations between gut microbes, caloric load, and nutrient absorption in humans. Am J Clin Nutr. 2011 Jul;94(1):58-65. doi: 10.3945/ajcn.110.010132. Epub 2011 May 4.

    PubMed 21543530

  • Pedersen HK, Gudmundsdottir V, Nielsen HB, Hyotylainen T, Nielsen T, Jensen BA, Forslund K, Hildebrand F, Prifti E, Falony G, Le Chatelier E, Levenez F, Dore J, Mattila I, Plichta DR, Poho P, Hellgren LI, Arumugam M, Sunagawa S, Vieira-Silva S, Jorgensen T, Holm JB, Trost K; MetaHIT Consortium; Kristiansen K, Brix S, Raes J, Wang J, Hansen T, Bork P, Brunak S, Oresic M, Ehrlich SD, Pedersen O. Human gut microbes impact host serum metabolome and insulin sensitivity. Nature. 2016 Jul 21;535(7612):376-81. doi: 10.1038/nature18646. Epub 2016 Jul 13.

    PubMed 27409811

  • Yoo JY, Kim SS. Probiotics and Prebiotics: Present Status and Future Perspectives on Metabolic Disorders. Nutrients. 2016 Mar 18;8(3):173. doi: 10.3390/nu8030173.

    PubMed 26999199

  • Fadrosh DW, Ma B, Gajer P, Sengamalay N, Ott S, Brotman RM, Ravel J. An improved dual-indexing approach for multiplexed 16S rRNA gene sequencing on the Illumina MiSeq platform. Microbiome. 2014 Feb 24;2(1):6. doi: 10.1186/2049-2618-2-6.

    PubMed 24558975

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Childhood, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of fecal microbial profile with childhood obesity (time frame: visit 1day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03388411, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.

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