The dose effects of butyrylated starch in patients with familial adenomatous polyposis.

Phase 2

Recruiting

• Conditions: familial adenomatous polyposis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12611000466943
• Lead Sponsor: Commonwealth Scientific and Industrial Research Organisation (CSIRO) Preventative Health National Research Flagship

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Age 18-75 years, male or female.
2. Generally in good health.
3. Patients with familial adenomatous polyposis with either ileorectal anastomosis or pouches.
4. Available for the duration of the study.
5. Willing to compy with faecal sample collection requirements.

Exclusion Criteria

1. Intolerance to high-fibre products
2. Reported lactating, pregnant or wish to become pregnant during the study. If the volunteer becomes pregnant during the trial they will be withdrawn.
3. Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
4. Recent or planned sureveillance endoscopy +/- bowel preparation within the trial period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To quantify the release of butyrate in the colon. Butyrate concentrations in faecal samples will be analysed using standard distillation procedures and gas chromatography.[At the beginning and end of each 14 day test period.];To determine the effects of consumption of the 3 doses of butyrylated high amylose maize starch on FAP patients' gastrointestinal quality of life using a validated assessement tool for evaluating the quality of life and distress for gastrointestinal symptoms (Eypasch et al., 1995 Gastrointestinal quality of life index: development, validation and application of a new instrument; British Journal of Surgery, 82, 216-222.)[At baseline and the end of each test period.]

Secondary Outcome Measures

Name	Time	Method
To examine the normal diet of FAP patients using repeated 24 hour diet diaries which will be collected for 2 weekdays and 1 weekend day.[At baseline and during the 2 washout periods.]