Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis?

Colorectal Carcinoma Clinical Trial

— EPEC  

Official title:

ROLE OF E COLI IN Colorectal Tumourigenesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373020
• Other study ID #: e coli
• Status: Completed
• Phase: N/A
• First received: February 16, 2015
• Last updated: April 7, 2015
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: February 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Despite the characterization of many aetiologic genetic changes. The specific causative factors in the development of sporadic colorectal cancer remain unclear. This study was performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in developing colorectal carcinoma.

Description:

Fresh biopsy specimens have been obtained from the colonic mucosa overlying the colorectal cancer as well as from the colon of the healthy controls. Culture, genotyping and virulence of EPEC were done using (nutrient broth culture, and PCR). Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with colorectal carcinoma after have been diagnosed

Exclusion Criteria:

• Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinogenesis
• Colorectal Carcinoma
• Enteropathogenic Escherichia Coli .

Intervention

Other:
• colonoscopic biopsies

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	virulence genes: eaeA, bfpA and stx. PCR	E. coli colonies isolated from the mucosa of colorectal cancers and from healthy controls were harvested and subjected to DNA extraction (QIAGEN)	1 week	Yes
Secondary	EPEC serogrouping:	Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests to detect EPEC using O-specific nonavalent E.coli antiserum (O26, O55, O86, O111, O114, O119, O124, O125, O126, O127, O128, O142), according to the manufacturer's instructions (Bio-Rad).	1 week	Yes
Secondary	Strains: OF E COLI	The specimens were immediately transferred to the lab, inoculated in nutrient broth and vortexed for a few seconds then incubated overnight. The following day the broth culture was subcultured on enteric isolation media. Identification of E. coli was carried out by using standard biochemical methods.	1 week	Yes