The ENIGMA Study: Eastern Inflammatory Bowel Disease Gut Microbiota

NCT03462875 | Unknown

• 1 other identifier: ENIGMA II
• Study Type: observational
• Target: 532
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of inflammatory bowel diseases, (IBD) including Crohn's disease (CD) and ulcerative colitis (UC), is increasing in the developing world. Our recent Asia-Pacific population-based study in 8 Asian countries and Australia has demonstrated that Hong Kong and China have amongst the highest disease incidences in Asia while Australia has the equal highest incidence of these diseases in the world. The ENIGMA project comprises three main enteric microbiome domains of central importance to Crohn's disease. Two specific organisms which may play a critical role in disease pathogenesis, including the candidate protective bacterium, and the novel pathogenic candidate, will be characterized and studied in detail. Microbial findings will be related to a detailed assessment of environmental factors that permit microbial changes or expression.

Conditions

Crohn Disease

Keywords

Crohn Disease; Dietary pattern; Environmental factors; Gut microbiota

Outcome Measures

Primary Outcomes (1)

• Identification of Key Microbiota

  To study key identified bacteria and broader aspects of the microbiota that may play a role in Crohn's disease pathophysiology, in patients and healthy controls, in Asian and Western populations

  2 years

Secondary Outcomes (5)

• Influence of Dietary Factors

  2 years

• Influence of Environmental Factors

  2 years

• Relationship between environmental factor and Crohn's disease

  2 years

• Relationship between environmental factor and Crohn's disease related Mircobiota

  2 years

• Target Therapy for Crohn's Disease

  2 years

Study Arms (4)

Crohn's Disease Patients

Subjects having confirmed diagnosis of Crohn's disease which is defined by endoscopy, radiology and histology; and having documented ileocaecal or right-sided colonic disease

Non-household Controls

Non-affected subjects who will under colonoscopy for polyp or colorectal cancer screening, or investigations of gastrointestinal symptoms other than Inflammatory Bowel Disease

First Degree Relatives

Non-affected first degree relatives of cases

Household/co-habitant Controls

Non-affected subjects living in the same household with the cases in the recent 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Cases are those subjects having confirmed diagnosis of Crohn's disease which is defined by endoscopy, radiology and histology; and having documented ileocaecal or right-sided colonic disease; 2. Non-household controls are non-affected subjects who will under colonoscopy for polyp or colorectal cancer screening, or investigations of gastrointestinal symptoms other than Inflammatory Bowel Disease 3. Household/co-habitant controls are non-affected subjects living in the same household with the cases in the recent 6 months 4. FDR are the non-affected first degree relatives of cases.

You may qualify if:

• aged ≥18 years old
• competent to provide informed consent (no mental illness or dementia, etc. that will hinder the understanding)
• living in the same area for recent 6 months

You may not qualify if:

• Use of anticoagulants within 1 week
• Use of prebiotics, probiotics or antibiotics in recent 3 months
• Use of laxatives or "Stoppers" in the last 3 months
• Vaccination within 3 months
• Recent dietary changes (e.g. becoming vegetarian/vegan)
• Known complex infections or sepsis (excl. simple infections such as influenza etc.)
• Known history or concomitant significant food allergies
• Known history of severe organ failure (including decompensated cirrhosis, malignant disease, kidney failure, epilepsy, active serious infection, acquired immunodeficiency syndrome)
• Bowel surgery in the last 6 months (excluding colonoscopy/ procedure related to perianal disease)
• Having stoma
• Known pregnancy
• Travel history within 4 weeks (need to define the travel history in China)
• Known contraindications to colonoscopy
• Colonoscopy in the last month prior to sampling

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• University of Melbourne: collaborator
• The University of Queensland: collaborator
• Sun Yat-sen University: collaborator
• Kunming Medical University: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Siew Chien Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 13, 2018
• Study Start: August 29, 2018
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

HK (1)