Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000466943
Ethics application status
Approved
Date submitted
5/05/2011
Date registered
5/05/2011
Date last updated
2/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The dose effects of butyrylated starch in patients with familial adenomatous polyposis.
Scientific title
A pilot study to determine the optimal dose of esterified butyrate in patients with familial adenomatous polyposis
Secondary ID [1] 260113 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
familial adenomatous polyposis 265791 0
Condition category
Condition code
Oral and Gastrointestinal 265942 265942 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 264529 0
Treatment: Other
Comparator / control treatment
The butyrylated high amylose maize starch will be compared at 3 different doses (5 g/d, 20 g/d and 40 g/d).
Control group
Dose comparison

Outcomes
Primary outcome [1] 266697 0
To quantify the release of butyrate in the colon. Butyrate concentrations in faecal samples will be analysed using standard distillation procedures and gas chromatography.
Timepoint [1] 266697 0
At the beginning and end of each 14 day test period.
Primary outcome [2] 266698 0
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.)
Timepoint [2] 266698 0
At baseline and the end of each test period.
Secondary outcome [1] 276213 0
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.
Timepoint [1] 276213 0
At baseline and during the 2 washout periods.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265017 0
Government body
Name [1] 265017 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Preventative Health National Research Flagship
Country [1] 265017 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Preventative Health National Research Flagship
Address
PO Box 10041
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 264111 0
None
Name [1] 264111 0
Address [1] 264111 0
Country [1] 264111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266992 0
Southern Adelaide Flinders Clinical Human Research Ethics Committee
Ethics committee address [1] 266992 0
Human Research Ethics Department
Room 2A/221 Level 2
Flinders Medical Centre
3 Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 266992 0
Australia
Date submitted for ethics approval [1] 266992 0
Approval date [1] 266992 0
13/07/2010
Ethics approval number [1] 266992 0
1/10/0138
Ethics committee name [2] 266993 0
CSIRO Food and Nutritional Sciences Human Research Ethics Committee
Ethics committee address [2] 266993 0
Po Box 10041
Adelaide SA 5000
Ethics committee country [2] 266993 0
Australia
Date submitted for ethics approval [2] 266993 0
Approval date [2] 266993 0
29/07/2010
Ethics approval number [2] 266993 0
10/15
Ethics committee name [3] 266996 0
Melbourne Health
Ethics committee address [3] 266996 0
PO Royal Melbourne Hospital
Parkville Victoria 3050
Ethics committee country [3] 266996 0
Australia
Date submitted for ethics approval [3] 266996 0
25/03/2011
Approval date [3] 266996 0
Ethics approval number [3] 266996 0
2011.040

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32572 0
Address 32572 0
Country 32572 0
Phone 32572 0
Fax 32572 0
Email 32572 0
Contact person for public queries
Name 15819 0
Jessica Southwood
Address 15819 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide SA 5000
Country 15819 0
Australia
Phone 15819 0
+61 8 8303 8927
Fax 15819 0
Email 15819 0
[email protected]
Contact person for scientific queries
Name 6747 0
Julie Clarke
Address 6747 0
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide SA 5000
Country 6747 0
Australia
Phone 6747 0
+61 8 8303 8925
Fax 6747 0
Email 6747 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.