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

A pilot study to determine the optimal dose of esterified butyrate in patients with familial adenomatous polyposis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000466943

Enrollment

Registered

2011-05-05

Start date

2011-01-14

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objectives of this pilot study are to determine the extent to which large bowel bacteria are capable of releasing esterified butyrate in FAP patients and to determine the acceptability of butyrylated high amylose maize starch in this participant group. This study will consist of three double blinded randomised cross over studies and the objectives will be determined by feeding 3 different doses of the butyrylated high amylose maize starch to FAP patients and measuring butyrate levels in their faeces. This study will provide information on the optimal dose for FAP patients to release esterified butyrate which will be used in a major clinical trial.

Interventions

A 3 x 3 double blind crossover study examining butyrylated high amylose maize starch at 3 dose rates (a) 5 g/d (b) 20 g/d (c) 40 g/d. There are 3 intervention periods of 14 days with a 7 day 'wash out' period between each intervention. The starch is to be ingested orally by way of combination (starch plus long life milk).

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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 If the volunteer becomes pregnant during the trial they will be withdrawn. 3.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.

Outcome results