NCT03515070

Brief Summary

Inflammatory bowel disease(IBD) is a chronic inflammatory condition for gastrointestinal tract. Regarding its pathogenesis, there has been numerous studies to reveal the complex association between genetic and environmental factors. In Korea, the incidence of IBD is growing rapidly but genetic studies solely including patients with Korean descent were not sufficient enough. Therefore, the investigators planned to conduct genetic and fecal microbial analysis for the 60 individuals from 30 Korean IBD families to find out the pathogenesis of IBD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

May 9, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

April 22, 2018

Last Update Submit

February 18, 2020

Conditions

Inflammatory Bowel Diseases

Keywords

Gastrointestinal MicrobiomeGenetics

Outcome Measures

Primary Outcomes (4)

  • Rare genetic variants of inflammatory bowel disease

    Results from whole genome sequencing of blood samples of study participants. Planned to compare with the previously reported variances.

    Three months after the sample collection

  • Common genetic variants of inflammatory bowel disease

    Results from genome-wide single nucleotide polymorphism array of blood samples of study participants. Planned to compare with the previously reported variances.

    Three months after the sample collection

  • Genetic risk score of inflammatory bowel disease

    Results from genome-wide single nucleotide polymorphism array of blood samples of study participants. Planned to compare with the previously reported variances.

    Three months after the sample collection

  • Fecal microbiome composition of each study subjects

    Microbial diversity measured from 16S RNA sequencing datas of fecal microbiomes.

    Three months after the sample collection

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators are planned to study family members with IBD(Crohn's disease or ulcerative colitis). They are all Koreal descent and study candidates are two patients from each 30 families. As a healthy internal control, another family member without IBD history will be also enrolled.

You may qualify if:

  • individuals from 30 families of Crohn's disease or ulcerative colitis.
  • Unaffected 30 individuals from each family as healthy internal control.

You may not qualify if:

  • Person with history of using antibiotics or probiotics within previous 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Medical Center

Seoul, 180-702, South Korea

Location

Related Publications (5)

  • Wellcome Trust Case Control Consortium. Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared controls. Nature. 2007 Jun 7;447(7145):661-78. doi: 10.1038/nature05911.

    PMID: 17554300BACKGROUND

  • Thia KT, Loftus EV Jr, Sandborn WJ, Yang SK. An update on the epidemiology of inflammatory bowel disease in Asia. Am J Gastroenterol. 2008 Dec;103(12):3167-82. doi: 10.1111/j.1572-0241.2008.02158.x.

    PMID: 19086963BACKGROUND

  • Lashner BA, Evans AA, Kirsner JB, Hanauer SB. Prevalence and incidence of inflammatory bowel disease in family members. Gastroenterology. 1986 Dec;91(6):1396-400. doi: 10.1016/0016-5085(86)90193-9.

    PMID: 3770366BACKGROUND

  • Stittrich AB, Ashworth J, Shi M, Robinson M, Mauldin D, Brunkow ME, Biswas S, Kim JM, Kwon KS, Jung JU, Galas D, Serikawa K, Duerr RH, Guthery SL, Peschon J, Hood L, Roach JC, Glusman G. Genomic architecture of inflammatory bowel disease in five families with multiple affected individuals. Hum Genome Var. 2016 Jan 7;3:15060. doi: 10.1038/hgv.2015.60. eCollection 2016.

    PMID: 27081563BACKGROUND

  • Jostins L, Ripke S, Weersma RK, Duerr RH, McGovern DP, Hui KY, Lee JC, Schumm LP, Sharma Y, Anderson CA, Essers J, Mitrovic M, Ning K, Cleynen I, Theatre E, Spain SL, Raychaudhuri S, Goyette P, Wei Z, Abraham C, Achkar JP, Ahmad T, Amininejad L, Ananthakrishnan AN, Andersen V, Andrews JM, Baidoo L, Balschun T, Bampton PA, Bitton A, Boucher G, Brand S, Buning C, Cohain A, Cichon S, D'Amato M, De Jong D, Devaney KL, Dubinsky M, Edwards C, Ellinghaus D, Ferguson LR, Franchimont D, Fransen K, Gearry R, Georges M, Gieger C, Glas J, Haritunians T, Hart A, Hawkey C, Hedl M, Hu X, Karlsen TH, Kupcinskas L, Kugathasan S, Latiano A, Laukens D, Lawrance IC, Lees CW, Louis E, Mahy G, Mansfield J, Morgan AR, Mowat C, Newman W, Palmieri O, Ponsioen CY, Potocnik U, Prescott NJ, Regueiro M, Rotter JI, Russell RK, Sanderson JD, Sans M, Satsangi J, Schreiber S, Simms LA, Sventoraityte J, Targan SR, Taylor KD, Tremelling M, Verspaget HW, De Vos M, Wijmenga C, Wilson DC, Winkelmann J, Xavier RJ, Zeissig S, Zhang B, Zhang CK, Zhao H; International IBD Genetics Consortium (IIBDGC); Silverberg MS, Annese V, Hakonarson H, Brant SR, Radford-Smith G, Mathew CG, Rioux JD, Schadt EE, Daly MJ, Franke A, Parkes M, Vermeire S, Barrett JC, Cho JH. Host-microbe interactions have shaped the genetic architecture of inflammatory bowel disease. Nature. 2012 Nov 1;491(7422):119-24. doi: 10.1038/nature11582.

    PMID: 23128233BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and fecal sample from each study subjects * DNA extraction will be performed soon after the blood sampling. * Fecal sample will be prepped for the microbiome analysis and microbial 16 S RNA will be extracted from the sample.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Hyo Jong Kim, M.D. PhD

    Kyung Hee University Hospital

    PRINCIPAL INVESTIGATOR

  • Chang Kyun Lee, M.D. PhD

    Kyung Hee University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 22, 2018

First Posted

May 3, 2018

Study Start

May 9, 2018

Primary Completion

September 30, 2019

Study Completion

December 30, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

KR(1)