Advanced Metagenomic Analysis of Human Gastrointestinal Microbiota in Patients With Chronic Gastrointestinal (GI) Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by King Fahad Medical City.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
King AbdulAziz City for Science and Technology
Information provided by:
King Fahad Medical City
ClinicalTrials.gov Identifier:
NCT01099111
First received: April 1, 2010
Last updated: April 5, 2010
Last verified: February 2010
  Purpose

This clinical trial hypothesize that Gut Microbiota (bacteria, viruses, fungi)play a major role in the occurrence and progression of many chronic gastrointestinal diseases like Irritable Bowel Syndrome, Inflammatory Bowel Diseases and Colo-Rectal Cancer.

Hence, aims to study the spectrum of such microbiota in these patients as compared to normal subjects, by utilizing metagenomic techniques rather than cultural methods.


Condition
Irritable Bowel Syndrome
Colitis, Ulcerative
Crohn Disease
Adenomatous Polyps
Colonic Neoplasm

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Advanced Metagenomic Analysis of Human Gastrointestinal Microbiota in Patients With Chronic GI Disorders (IBS, IBD, CRC)

Resource links provided by NLM:


Further study details as provided by King Fahad Medical City:

Primary Outcome Measures:
  • mucosa associated microbiota pattern [ Time Frame: one year ] [ Designated as safety issue: No ]
    collection of samples as per protocol and characterizing the pattern numerically in each subject of the study groups and compare them to controls


Secondary Outcome Measures:
  • mobile metagenomes pattern [ Time Frame: six months ] [ Designated as safety issue: No ]
    mobile metagenomics looks at the mobile microbiota rather than only the mucosal and try to explain differences in patterns. This will be looked at according to feasibility and funding availability.


Biospecimen Retention:   Samples With DNA

colonic washing samples of every subject will be retained for 16S rRNA analysis for the study purpose, and some more samples will be retained for further later on analysis


Estimated Enrollment: 250
Study Start Date: May 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
IBS
Irritable Bowel Syndrome patients
UC
Ulcerative Colitis patients
CD
Crohn's Disease patients
CRAP
Colo Rectal Adenomatous Polyps patients
CRC
Colo Rectal Cancer patients
Control
Normal Subjects

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We propose to recruit our cohort of patients from the King Fahad Medical City in Riyadh (largest tertiary care hospital of Saudi MOH with wide open referral system), over one year between May 2010 and May of 2011. Twenty five participants with each of the focus conditions (IBS, UC, CD, CR adenomatous polyps, CRC) will be compared to twenty five participants with no GI complaints and have a normal colonic mucosa (by endoscopic and histological examination).

Criteria

Inclusion Criteria:

IBS: 25 consecutive patients presenting to KFMC GI service after launching the project on Jan 2010, will be recruited if they meet the following conditions:

  1. Meet the diagnostic criteria as per ROME-II classification and as judged by experienced consultants for not less than 5 years.
  2. IBS with diarrhea or constipation or mixed predominance pattern will be included.
  3. Standard diagnostic tests have to be done to exclude any possible organic lesion to explain the abdominal pain, and all have to be negative.

IBD: from the KFMC GI service database, 25 Ulcerative Colitis (UC) and 25 Crohn's Disease (CD) will be selected according to following:

  1. Confirmed diagnosis as CD or UC based on clinical, endoscopic and histological criteria.
  2. Specifically did not use antibiotics for last 6 months before enrollment.
  3. Detailed information about current treatment regimen has to be provided, and current use of 5-ASA, Steroid or Azathioprine will not hold from enrolling the patients as we cannot have patients off any one or more of these medications. (Obviously, we cannot exclude effects of these medications on microbiota, but it is not the focus of the current study).
  4. None of the patients selected would be on anti-TNF medications. CRC: 25 consecutive cases of confirmed CRC and 25 consecutive cases of adenomatous CR polyposis as per histological diagnosis made by 2 experienced pathologists will be included.

Normal Subjects: 25 normal control groups that are matched for age and sex to the other 3 disease groups will be selected from consecutive CRC screening colonoscopy subjects who get referred to KFMC GI service during the study period, and proved to have no GI disorders. 15 will be selected from Urban and 10 from Rural areas of KSA.

Exclusion Criteria:

  1. Treatment with antibiotics for the last 6 months before enrollment.
  2. Absence of recent infective colitis, bowel obstruction, or abdominal surgery.
  3. Not on any medication that may affect gut microbiota, like: cholestyramine, ursodeoxycholic acid, gut prokinetic agents.
  4. Refusal to comply with the unified bowel preparation instructions for all cases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099111

Contacts
Contact: Ahmed O AlOmair, MD +96612889999 ext 8771 aalomair@kfmc.med.sa
Contact: Ali Al Shanqeeti, MD ashanqeeti@kfmc.med.sa

Locations
Saudi Arabia
KFMC Not yet recruiting
Riyadh, Saudi Arabia, 11525
Contact: Imad Tleyjeh    +96612889999 ext 9680    itleyjeh@kfmc.med.sa   
Sub-Investigator: Ali Al Shanqeeti, MD         
Sub-Investigator: Essam Yamany, PhD         
Sub-Investigator: Adel Al Qutub, MD         
Sub-Investigator: Khalid Al Sayari, MD         
Sub-Investigator: Abid Al Lehaibi, MD         
Sponsors and Collaborators
King Fahad Medical City
King AbdulAziz City for Science and Technology
Investigators
Principal Investigator: Ahmed O AlOmair, MD KFMC
  More Information

No publications provided

Responsible Party: Ahmed Al Omair, MD - Consultant Gastroenterologist / Head, Gastroenterology Department, KFMC
ClinicalTrials.gov Identifier: NCT01099111     History of Changes
Other Study ID Numbers: 09 -116, 243 - 29 - AT
Study First Received: April 1, 2010
Last Updated: April 5, 2010
Health Authority: Saudi Arabia: King AbdulAziz City for Science and Technology

Keywords provided by King Fahad Medical City:
IBS
UC
CD
CRAP
CRC

Additional relevant MeSH terms:
Neoplasms
Colitis
Colitis, Ulcerative
Colonic Neoplasms
Crohn Disease
Irritable Bowel Syndrome
Ulcer
Adenomatous Polyps
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases, Functional
Pathologic Processes
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 17, 2014