Advanced Metagenomic Analysis of Human Gastrointestinal Microbiota in Patients With Chronic Gastrointestinal (GI) Disorders
Recruitment status was Not yet recruiting
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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 |
|---|
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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) |
- 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
- 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 |
|---|
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IBS
Irritable Bowel Syndrome patients
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UC
Ulcerative Colitis patients
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CD
Crohn's Disease patients
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CRAP
Colo Rectal Adenomatous Polyps patients
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CRC
Colo Rectal Cancer patients
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Control
Normal Subjects
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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 |
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).
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:
- Meet the diagnostic criteria as per ROME-II classification and as judged by experienced consultants for not less than 5 years.
- IBS with diarrhea or constipation or mixed predominance pattern will be included.
- 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:
- Confirmed diagnosis as CD or UC based on clinical, endoscopic and histological criteria.
- Specifically did not use antibiotics for last 6 months before enrollment.
- 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).
- 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:
- Treatment with antibiotics for the last 6 months before enrollment.
- Absence of recent infective colitis, bowel obstruction, or abdominal surgery.
- Not on any medication that may affect gut microbiota, like: cholestyramine, ursodeoxycholic acid, gut prokinetic agents.
- Refusal to comply with the unified bowel preparation instructions for all cases.
Contacts and Locations| Contact: Ahmed O AlOmair, MD | +96612889999 ext 8771 | aalomair@kfmc.med.sa |
| Contact: Ali Al Shanqeeti, MD | ashanqeeti@kfmc.med.sa |
| 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 | |
| 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:
|
Colonic Neoplasms Neoplasms Colitis Colitis, Ulcerative 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 May 19, 2013