FishGastro Study: Fish Consumption and Gastro-Intestinal Health

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00145015
• Date of registration: 01/09/2005
• Prospective Registration: No
• Primary sponsor: Institute of Food Research
• Public title: FishGastro Study: Fish Consumption and Gastro-Intestinal Health
• Scientific title: Fish Consumption and Gastro-Intestinal Health With Special Emphasis on Reduction of Risk of Colon Cancer and Inflammatory Bowel Disease
• Date of first enrolment: December 2004
• Target sample size: 270
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00145015
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Netherlands, United Kingdom

Contacts

• Name: Elizabeth K Lund, PhD
• Affiliation: Institute of Food Research

Key inclusion & exclusion criteria

Inclusion Criteria:

Ulcerative Colitis Patient Group (Group 1):

- Aged 18 - 80

- Male or female

- Diagnosed with ulcerative colitis

- Attending gastroenterology clinic for routine colonoscopy check-up

- Willing to increase dietary intake of fish for six months

- Willing to undergo a flexible sigmoidoscopy examination

Polyps/Resection Group (Group 2):

- Aged 18 - 80

- Male or female

- A history of polyps in the colon

- Attending gastroenterology clinic for routine colonoscopy check-up

- Willing to increase dietary intake of fish for six months

- Willing to undergo a flexible sigmoidoscopy examination

Control Group (Group 3):

- Aged 18 - 80

- Male or female

- Booked for a colonoscopy examination for the investigation of iron deficiency anaemia
of unknown cause (no evidence of macroscopic disease found during examination)

- Willing to increase dietary intake of fish for six months

- Willing to undergo a flexible sigmoidoscopy examination

Exclusion Criteria:

Ulcerative Colitis Patient Group (Group 1) and Polyps/Resection Group (Group 2):

- Allergic to fish

- Receiving anticoagulant therapy

- Diabetics

- Pregnant or breast-feeding

- Organ transplant recipients receiving immunosuppression therapy

- Prosthetic heart valve

- Allergic to pethidine

- Previous diagnosis of bacterial endocarditis

Control Group (Group 3):

Same as Groups 1 and 2 plus:

- Received a diagnosis of colorectal cancer following initial investigative colonoscopy
(volunteer will be withdrawn from the study when diagnosed as requiring treatment)

- Received a diagnosis of coeliac disease following initial investigative colonoscopy
(volunteer will be withdrawn from the study when diagnosed as requiring a modified
diet)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Polyps

Colorectal Cancer

Intervention(s)

Behavioral: Increased dietary intake of salmon or cod

Primary Outcome(s)

Apoptosis in colonic biopsy samples

Secondary Outcome(s)

faecal water cytotoxicity and genotoxicity

Cell proliferation

gene transcription

circulating inflammatory markers (cytokines and prostaglandins)

lymphocyte infiltration

tissue inflammatory markers (cytokines and prostaglandins)

Secondary ID(s)

IFR02/2004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Food Standards Agency, United Kingdom

University of Jena

European Commission

Wageningen University

University of East Anglia