NCT04748627

Brief Summary

Crohn's disease (CD) and Ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) of unknown etiology. The pathophysiology of IBD relates to the mucosal immune response to antigenic stimulation from the gut microbiota secondary to environmental influence, on a background of genetic susceptibility. IBD represents an important public health problem because it affects mostly young people at an age when they are most active in their private and professional life, and a management challenge because of its unpredictable relapsing nature. During the last few decades the incidence of IBD has changed in many ways. Incidence rates of traditionally high incidence areas such as the United States and Europe is remaining relatively stable or even decreasing, while the diseases have become more prevalent in previously low incidence areas, including Asia. Our latest systematic review has demonstrated that the highest reported prevalence of IBD was still in Europe and North America, however, the incidence of IBD has been rising in newly industrialized countries since 1990.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 9, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

February 9, 2021

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of IBD

    To determine the incidence of IBD in 19 regions globally, and to investigate if this increase is caused by environmental and dietary factors.

    1 year

Secondary Outcomes (1)

  • Geographical effect

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

For IBD patients: Newly diagnosed IBD patients in the local area For heathy control: Asymptomatic adults who have no IBD or any other chronic medical illnesses.

You may qualify if:

  • Aged ≥ 18 years old
  • Confirmed diagnosis of Crohn's disease or Ulcerative Colitis according to established clinical, endoscopic and histological criteria
  • Written informed consent obtained

You may not qualify if:

  • Nil
  • For healthy control:
  • Aged ≥ 18 years old
  • Asymptomatic
  • Written informed consent obtained
  • Diagnosis of any chronic medical illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Siew Chien Ng, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 10, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations