Clinical trial · Observational
Advanced Metagenomic Analysis of Human Colonic Microbiota in Patients With Chronic GI Disorders
Advanced Metagenomic Analysis of Human Colonic Microbiota in Patients With Chronic Gastrointestinal Disorders (IBS, IBD, CRC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis, Ulcerative | — | UNRESOLVED | — |
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Crohn Disease | — | UNRESOLVED | — |
| Irritable Bowel Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (5)
- label
- Irritable Bowel Syndrome
- description
- only one Colonoscopy with mucosal washing samples collection at the time of recruitment
- label
- Ulcerative Colitis
- description
- only one Colonoscopy with mucosal washing samples collection at the time of recruitment
- label
- Crohn's Disease
- description
- only one Colonoscopy with mucosal washing samples collection at the time of recruitment
- label
- Colo Rectal Cancer
- description
- only one Colonoscopy with mucosal washing samples collection at the time of recruitment
- label
- Control: Normal Subjects
- description
- only one Colonoscopy with mucosal washing samples collection at the time of recruitment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: IBS: 50 consecutive patients presenting to KFMC GI service after launching the project on July 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, 50 Ulcerative Colitis (UC) and 50 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: 50 consecutive cases of confirmed CRC as per histological diagnosis made by 2 experienced pathologists will be included. Feasibility to do full colonoscopy before any surgical resection would be a condition to recruit any patient. Normal Subjects: 50 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. 25 will be selected from Urban and 25 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 colonic/small intestinal resection 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.
References
Publications (0)
Data not yet available