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
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