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The ENIGMA Study: Eastern Inflammatory Bowel Disease Gut Microbiota

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ClinicalTrials.gov Identifier: NCT03462875
Recruitment Status : Unknown
Verified March 2018 by Siew Chien NG, Chinese University of Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
University of Melbourne
The University of Queensland
RenJi Hospital
Sun Yat-sen University
Air Force Military Medical University, China
Chinese PLA General Hospital
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

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 characterised and studied in detail. Microbial findings will be related to detailed assessment of environmental factors that permit microbial changes or expression.


Condition or disease
Crohn's Disease Microbiota Dietary Pattern Environmental Factors

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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The ENIGMA Study: Eastern Inflammatory Bowel Disease Gut Microbiota
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort
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



Primary Outcome Measures :
  1. Identification of Key Microbiota [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Influence of Dietary Factors [ Time Frame: 2 years ]
    To address the influence of dietary additives exposures on the etiology and prevalence of Inflammatory Bowel Diseases

  2. Influence of Environmental Factors [ Time Frame: 2 years ]
    To address the influence of environmental exposures on the etiology and prevalence of Inflammatory Bowel Diseases

  3. Relationship between environmental factor and Crohn's disease [ Time Frame: 2 years ]
    To evaluate which environmental factors will cause Crohn's disease

  4. Relationship between environmental factor and Crohn's disease related Mircobiota [ Time Frame: 2 years ]
    To evaluate the environmental factors and the microbiota in Crohn's disease

  5. Target Therapy for Crohn's Disease [ Time Frame: 2 years ]
    To target microbial factors as therapy in Crohn's disease



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462875


Contacts
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Contact: Siew Chien Ng, PhD 852-35053996 siewchienng@cuhk.edu.hk
Contact: Jessica Ching, MPH 852-35053524 jessicaching@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Contact: Siew Chien Ng, PhD    35053996    siewchienng@cuhk.edu.hk   
Contact: Jessica Ching, MPH    35053524    jessicaching@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
University of Melbourne
The University of Queensland
RenJi Hospital
Sun Yat-sen University
Air Force Military Medical University, China
Chinese PLA General Hospital
Investigators
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Principal Investigator: Siew Chien Ng, PhD Chinese University of Hong Kong
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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03462875    
Other Study ID Numbers: ENIGMA II
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Siew Chien NG, Chinese University of Hong Kong:
Crohn's Disease
Microbiota
Dietary Pattern
Environmental factors
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases