Status:
COMPLETED
FishGastro Study: Fish Consumption and Gastro-Intestinal Health
Lead Sponsor:
Quadram Institute Bioscience
Collaborating Sponsors:
Wageningen University
University of Jena
Conditions:
Colorectal Cancer
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of the study is to determine whether increasing the dietary intake of n-3 fatty acids by the consumption of oil-rich fish reduces the risk of developing colorectal cancer.
Detailed Description
Epidemiological evidence from several countries supports a protective effect of fish consumption on cancer risk and gastrointestinal cancers in particular. Further evidence to support the idea that fi...
Eligibility Criteria
Inclusion
- 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
- 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- Received a diagnosis of colorectal cancer following initial investigative colonoscopy (volunteer will be withdrawn from the study when diagnosed as requiring treatment)
- Received a diagnosis of coeliac disease following initial investigative colonoscopy (volunteer will be withdrawn from the study when diagnosed as requiring a modified diet)
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00145015
Start Date
December 1 2004
End Date
April 1 2008
Last Update
July 30 2008
Active Locations (2)
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1
University of Wageningen
Wageningen, Netherlands
2
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA