Condition category
Cancer
Date applied
15/11/2010
Date assigned
14/12/2010
Last edited
14/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Theo de Kok

ORCID ID

Contact details

Universiteitssingel 50
Maastricht
6229 ER
Netherlands
+31 (0)43 3881091
t.dekok@grat.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A non-randomised controlled trial to compare the effect of colon inflammation in combination with a 7-day 300 grams/day red meat diet on the endogenous formation of potentially carcinogenic N-nitroso compounds in the colon of inflammatory bowel disease patients versus non-inflamed irritable bowel syndrome patients, in relation to colorectal cancer risk

Acronym

Study hypothesis

We hypothesise that both colon inflammation and a diet high in red meat increase the endogenous formation of potentially carcinogenic N-nitroso compounds in the human colon and that these compounds increase the colorectal cancer risk, which could (partially) explain the increased colorectal cancer risk that is associated with inflammatory bowel disease and diets high in red meat.

Inflammatory bowel disease is characterised by a chronic inflammation within the gastrointestinal tract, which, in case of ulcerative colitis, is present in the colon and rectum.

Ethics approval

The Medical Ethical Approval Committee (METC) Atrium Orbis Zuyd in Heerlen approved on the 23rd January 2007 (ref: METC 04-P-04A; reg no: NL13359.096.06)

Study design

Non-randomised interventional multicentre study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Inflammatory bowel disease; colorectal cancer risk

Intervention

Both inflammatory bowel disease patients and irritable bowel syndrome control patients participate in a 7-day dietary intervention in which 300 grams of red meat products (steak, etc) are consumed daily. Collection of colon biopsies by endoscopic examination, blood collection by venipuncture, and urine and faecal matter collection takes place at the beginning and the end of the dietary intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Whole genome gene expression modifications by microarray analysis (4x44K Agilent platform)
2. Apparent total nitroso compounds in faecal matter by thermal energy analysis
3. Faecal water genotoxicity (30 minute exposure to 10% faecal water) by comet assay analysis in the adenocarcinoma cell line Caco-2

All outcomes are measured at baseline and post intervention.

Secondary outcome measures

1. Calprotectin levels in faecal matter as a measure of inflammation
2. Analysis of food frequency questionnaires recorded during intervention period
3. Possible determination of N-nitroso compound levels by thermal energy analysis in urine and blood

All outcomes are measured at baseline and post intervention.

Overall trial start date

23/01/2007

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Inflammatory bowel disease patients with an active form of ulcerative colitis with a moderate exacerbation of their disease and in whom the inflammation does not go beyond the flexure lienalis
2. Irritable bowel syndrome control patients with endoscopically proven absence of inflammation and adenomas
3. Participants of any age (above 18 years) and either sex are included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 participants in total, of whom 40 inflammatory bowel disease (ulcerative colitis) patients and 40 control patients with irritable bowel syndrome.

Participant exclusion criteria

1. Inflammatory bowel disease patients with severe inflammation, including Crohn's disease and pancolitis
2. Irritable bowel syndrome control patients with medical complaints and/or use of anti-inflammatory medication

Recruitment start date

23/01/2007

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Universiteitssingel 50
Maastricht
6229 ER
Netherlands

Sponsor information

Organisation

Maastricht University (Netherlands)

Sponsor details

Universiteitssingel 50
Maastricht
6229 ER
Netherlands
+31 (0)43 3881091
t.dekok@grat.unimaas.nl

Sponsor type

University/education

Website

http://www.maastrichtuniversity.nl/

Funders

Funder type

University/education

Funder name

Maastricht University (Netherlands) - internal funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes