Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000422325
Ethics application status
Not yet submitted
Date submitted
24/07/2008
Date registered
25/08/2008
Date last updated
25/08/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Going through the motions: effect of a high-fibre wheat bran and fruit supplement on bowel-movement frequency and suppository use in aged care residents with constipation
Scientific title
Effect of a high-fibre wheat bran and fruit supplement on bowel-movement frequency and suppository use in aged care residents with constipation.
Secondary ID [1] 679 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation in aged care residents 3459 0
Condition category
Condition code
Diet and Nutrition 3617 3617 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group receive no fibre supplement during month 1, then receive
50 grams of the high-fibre dietary supplement per day orally during month 2 and 3, then receive 100 grams of the high-fibre dietary supplement per day orally during month 4 and 5. Bowel frequency and suppository use data are collected during month 1, 3 and 5.
Each 100 gram serve of high-fibre dietary supplement contains approximately 55 ml prune juice, 19 grams processed wheat bran and 26 grams pureed apple. The supplement contains 6.4 grams of dietary fibre per 100 gram serve.
Intervention code [1] 3186 0
Treatment: Other
Intervention code [2] 3187 0
Prevention
Comparator / control treatment
No treatment. Control subjects do not receive the high-fibre dietary supplement. Bowel frequency and suppository use data are collected during month 1, 3 and 5.
Control group
Active

Outcomes
Primary outcome [1] 4509 0
Number of bowel actions per month
Timepoint [1] 4509 0
Month 1, month 3 and month 5
Secondary outcome [1] 7629 0
Number of suppositories required per month
Timepoint [1] 7629 0
Month 1, month 3 and month 5

Eligibility
Key inclusion criteria
Resident of aged care facility in Bendigo,
Age > 65 years,
History of constipation for > 12 months,
Constipation: Fewer than 3 bowel movements per week and a requirement for regular laxatives and suppositories,
Provision of written consent from subject or guardian
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Colonic obstruction from neoplasms or stenosing diverticular disease,
Chronic intestinal pseudo-obstruction,
Hyperthyroidism,
Severe renal impairment,
Inflammatory bowel disease,
Anti-diarrhoeal therapy,
Tube feeding,
Palliative status.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by Excel Computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3641 0
Hospital
Name [1] 3641 0
Bendigo Health
Country [1] 3641 0
Australia
Primary sponsor type
Hospital
Name
Bendigo Health
Address
PO Box 126
VIC 3552
Country
Australia
Secondary sponsor category [1] 3275 0
None
Name [1] 3275 0
Address [1] 3275 0
Country [1] 3275 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5694 0
Ethics committee address [1] 5694 0
Ethics committee country [1] 5694 0
Date submitted for ethics approval [1] 5694 0
10/10/2008
Approval date [1] 5694 0
Ethics approval number [1] 5694 0

Summary
Brief summary
The study aims to determine the effect of a high-fibre processed wheat bran and fruit dietary supplement on bowel-movement frequency and suppository use in aged residents with chronic idiopathic constipation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28779 0
Address 28779 0
Country 28779 0
Phone 28779 0
Fax 28779 0
Email 28779 0
Contact person for public queries
Name 11936 0
Joy Blackburn
Address 11936 0
Dietetics Department
PO Box 126
Bendigo Health
VIC 3552
Country 11936 0
Australia
Phone 11936 0
03 54548060
Fax 11936 0
03 54547107
Email 11936 0
jblackburn@bendigohealth.org.au
Contact person for scientific queries
Name 2864 0
Nicole Kellow
Address 2864 0
Dietetics Department
PO Box 126
Bendigo Health
VIC 3552
Country 2864 0
Australia
Phone 2864 0
03 54548067
Fax 2864 0
03 54547107
Email 2864 0
nkellow@bendigohealth.org.au

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.