Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000220268
Ethics application status
Approved
Date submitted
8/01/2018
Date registered
12/02/2018
Date last updated
12/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
High amylase resistant starch to decrease stool output in people with short bowel syndrome
Scientific title
High amylase resistant starch to decrease stool output in people with short bowel syndrome
Secondary ID [1] 293732 0
Nil
Universal Trial Number (UTN)
U1111-1207-3542
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Short Bowel Syndrome 306101 0
Condition category
Condition code
Oral and Gastrointestinal 305224 305224 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
Addition of 50g per day of high amylase resistant starch to usual diet to determine changes in stool output.
Participants will act as their own control as this is a crossover trial. Each participant will complete the control and intervention arm of the trial.
Each arm of the trial will last for 1 week, as week one is a control (usual diet and fluids) period no wash out is required.
Participants will self administer the resistant starch by adding 1tbl per glass of St marks solution 4 times daily.
Resistant starch is a soluble tasteless powder which is undetectable in food and fluids.
Intervention code [1] 299984 0
Treatment: Other
Comparator / control treatment
Participants will act as their own control by completing a one week observation period prior to the intervention.
The control period involves the participants taking their usual diet which includes 1L per day of st Marks oral rehydration solution. Participants are advised not to make any changes to their usual diet during the control / intervention
Control group
Active

Outcomes
Primary outcome [1] 304378 0
Total daily stool output (g/d) measured via collecting, weighing and then discarding the stool on days 2, 4 and 7 of each trial week.
Timepoint [1] 304378 0
Stool output (g/d) will be measured on days 2, 4 and 7 of each trial week (i.e. both control and intervention period)..
Secondary outcome [1] 341775 0
Number of daily bowel actions recorded daily by the participant in the participant diary
Timepoint [1] 341775 0
Daily for the two weeks of intervention, Results of control versus intervention are then compared.

Eligibility
Key inclusion criteria
Adults with short bowel syndrome and colon in continuity
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fluid restriction
Absence of colon
Inability to take food / fluids orally

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not required as cross over trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
paired t tests

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/10/2013
Date of last participant enrolment
Anticipated
Actual
6/01/2016
Date of last data collection
Anticipated
Actual
18/02/2016
Sample size
Target
8
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9698 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 18467 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298346 0
Hospital
Name [1] 298346 0
Austin Health
Country [1] 298346 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley road
Heidelberg 3084
Victoria
Country
Australia
Secondary sponsor category [1] 297470 0
None
Name [1] 297470 0
Address [1] 297470 0
Country [1] 297470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299339 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 299339 0
145 Studley road
Heidelberg 3084
Victoria
Ethics committee country [1] 299339 0
Australia
Date submitted for ethics approval [1] 299339 0
18/02/2013
Approval date [1] 299339 0
07/04/2013
Ethics approval number [1] 299339 0
H2013 / 04982

Summary
Brief summary
Short bowel syndrome is defined as not having enough bowel to be able to absorb enough nutrition from food to maintain body weight. Short bowel syndrome causes diarrhoea and large fluid losses as a result of not being able to absorb what has been eaten / drunk. This means many people with short bowel syndrome rely on intravenous nutrition and or hydration.

Recent studies have shown that adding resistant starch (a form of carbohydrate found in food) to rehydration solutions that you drink can reduce diarrhoea in cases from a number of different causes. There are no studies investigating the use of resistant starch to reduce stool output in participants with short bowel syndrome.

It appears as though resistant starch works when it is fermented by the bacteria that live in the large bowel. A by-product of this fermentation are short chain fatty acids (SCFA). SCFA’s increase the large bowel’s ability to absorb water and salts leading to less diarrhoea and fluid loss.

The aim of this study is to determine if adding resistant starch to a rehydration solution that you drink can reduce diarrhoea and fluid loss in people with short bowel syndrome. If it is effective it may have the potential to reduce the amount of IV fluids needed for some people.

Resistant starch is present naturally in some foods and is approved as a food additive to increase the dietary fibre content.

This trial is aimed to determine if resistant starch can decrease diarrhea in people with short bowel syndrome.

It is a 2 week trial. Participants will complete both the control and the intervention.
In the treatment group you will be provided with 50g of starch powder to add to St Marks’s oral rehydration solution. You will be asked to drink 4 glasses of St Mark’s solution daily, each containing a tablespoon of the powder.

In the control group participants will be asked to drink 4 glasses of St Mark’s solution daily without any additions.

During each study period participants will otherwise eat and drink as normal and asked not to make any dietary changes during the study periods.

During the trial period participants will be asked to record the number of bowel actions they have each day and on days 2, 4 and 7 you will be asked to weigh each bowel action with scales that will be provided to record a daily total.

Results will be compared between groups
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80110 0
Ms Kate Hamilton
Address 80110 0
Nutrition Department, Austin Health
145 Studley road
Heidelberg 3084
Victoria
Country 80110 0
Australia
Phone 80110 0
61 03 9496 5011
Fax 80110 0
61 03 94963168
Email 80110 0
kate.hamilton2@austin.org.au
Contact person for public queries
Name 80111 0
Ms Kate Hamilton
Address 80111 0
Nutrition Department, Austin Health
145 Studley road
Heidelberg 3084
Victoria
Country 80111 0
Australia
Phone 80111 0
61 03 9496 5011
Fax 80111 0
61 03 9496 3168
Email 80111 0
kate.hamilton2@austin.org.au
Contact person for scientific queries
Name 80112 0
Ms Kate Hamilton
Address 80112 0
Nutrition Department, Austin Health
145 Studley road
Heidelberg 3084
Victoria
Country 80112 0
Australia
Phone 80112 0
61 03 9496 5011
Fax 80112 0
61 03 9496 3168
Email 80112 0
kate.hamilton2@austin.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
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