ACTRN12612000804886
Completed
Phase 2
A double blind, placebo controlled, randomised cross over trial to evaluate a novel and cost effective food supplement, butyrylated starch, on polyposis in familial adenomatous polyposis (FAP) patients.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Familial Adenomatous Polyposis
- Sponsor
- Royal Melbourne Hospital
- Enrollment
- 49
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Medically diagnosed FAP with either an intact colon, or after colectomy with a residual ileorectal anastomosis (IRA) or ileal pouch
- •2\. History of polyp detection at surveillance sigmoidoscopies or colonoscopies
- •3\. Generally in good health
- •4\. Available for the duration of the study
Exclusion Criteria
- •1\.Intolerant to high fibre products
- •2\.Reported lactating, pregnant or wish to become pregnant during the study. If a participant becomes pregnant during the trial they will be withdrawn
- •3\.Reported use of nonsteroidal anti\-inflammatory drugs, aspirin or probiotics
- •4\.Use of other medication or supplement that in the opinion of the gastroenterologist may interfere with polyp development or bowel or microbiota function for 2 months prior to and during the clinical intervention. Use of anti\-diarrhoeal medication(s) is allowed as required
- •5\.Use of antibiotics for 2 months prior to the commencement of the trial
- •6\.Use of other experimental chemopreventative agents, including EPA, tumeric and curcumin for 6 months prior to and during the trial
- •7\.Colonic or rectal surgery likely within 18 months.
Outcomes
Primary Outcomes
Not specified
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