Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000312246p
Ethics application status
Not yet submitted
Date submitted
8/02/2018
Date registered
2/03/2018
Date last updated
2/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does resistant starch reduce diarrhoea and improve nutrition and quality of life in people with short bowel syndrome
Scientific title
Does High Amylase Resistant Starch decrease stool output, improve nutrition and quality of life in people with short bowel syndrome?
Secondary ID [1] 293994 0
none
Universal Trial Number (UTN)
U1111-1209-1290
Trial acronym
Linked study record
ACTRN12618000220268 was a pilot trial providing proof of concept of the effectiveness of HARS to reduce stool output in short bowel syndrome. The current trial seeks to confirm this effect in a larger population.

Health condition
Health condition(s) or problem(s) studied:
Short bowel syndrome 306506 0
Condition category
Condition code
Oral and Gastrointestinal 305619 305619 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
50grams per day of high amylase resistant starch will be added into the diet of 50 people with short bowel syndrome (colon in continuity) for 2 months.
Participants will follow thier usual diet for the duration of the trial..
Participants will record compliance of the HARS on a checklist and return any unused portion of starch at the end of the trial
As the control period has no intervention there is no wash out period required between groups.
All participants will complete the control and intervention
Intervention code [1] 300270 0
Treatment: Other
Comparator / control treatment
This study is a crossover design. All participants will complete the control and intervention of the trial. During the control period (1 month) participants will collect baseline data including nutritional markers such as (weight, handgrip strength and mid upper arm circumference), Quality of Life, 2 x 24 hour urine collections, 2 x 24 hour stool measurements and record stool frequency and consistency on two days of each week.
Control group
Active

Outcomes
Primary outcome [1] 304732 0
Reduction in stool output in grams per day, This is assessed by weighing 24 hour stool output on 4 occasions during the trial (2 x control and 2 x intervention).
Timepoint [1] 304732 0
Measured on any 2 days of the control period (baseline month) and any 1 day of each month of the intervention period (2 months)
Primary outcome [2] 304733 0
Quality of life (as measured by EQD5
Timepoint [2] 304733 0
Quality of life is measured on enrollment (day 0) of the trial and on completion of the trial (day 90)
Primary outcome [3] 304734 0
Handgrip strength (measured via dynamometer)
Timepoint [3] 304734 0
Handgrip strength will be collected on enrollement into the trial (day 0) and on completion of the trial (day 90)
Secondary outcome [1] 342954 0
Stool frequency (number of bowel actions per day). Participants will record each bowel motion in a participant diary.
Timepoint [1] 342954 0
Stool frequency will be recorded on one weekday and one weekend day for the entire duration of the trial (90 days / 12 weeks)
Secondary outcome [2] 343356 0
Stool consistency (measured in type as per the Bristol Stool Chart
Timepoint [2] 343356 0
On 2 days per week of the control and intervention periods
Secondary outcome [3] 343357 0
Nutritional markers (weight, mid upper arm circumference)
Timepoint [3] 343357 0
Measured at the start and end of the trial

Eligibility
Key inclusion criteria
Short bowel syndrome with colon in continuity
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People without short bowel syndrome
People with short bowel syndrome without colon in continuity
Inability to take food / fluid orally
Gastrointestinal surgery within the past 6 months

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 applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pre and post treatment results will be compared between groups using paired t tests

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
Date of last participant enrolment
Anticipated
3/12/2018
Actual
Date of last data collection
Anticipated
4/03/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 9987 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 9988 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 9989 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 9990 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 18827 0
3084 - Heidelberg
Recruitment postcode(s) [2] 18828 0
2050 - Camperdown
Recruitment postcode(s) [3] 18829 0
4029 - Herston
Recruitment postcode(s) [4] 18830 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 298622 0
Hospital
Name [1] 298622 0
Austin Health
Country [1] 298622 0
Australia
Primary sponsor type
Hospital
Name
Intestinal Rehabilitation and Transplant Unit
Address
Austin Health Liver and Intestinal Transplant Unit
145 Studley Road
Heidleberg 3084
Country
Australia
Secondary sponsor category [1] 297787 0
None
Name [1] 297787 0
Address [1] 297787 0
Country [1] 297787 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299582 0
Austin Health Human Research Ethics Comittee
Ethics committee address [1] 299582 0
Austin Health HREC
145 Studley Road
Heidleberg 3084
Ethics committee country [1] 299582 0
Australia
Date submitted for ethics approval [1] 299582 0
28/02/2018
Approval date [1] 299582 0
Ethics approval number [1] 299582 0

Summary
Brief summary
Short bowel syndrome (SBS) is defined as having insufficient bowel to absorb the necessary nutrition and hydration to maintain weight / sustain growth. The aetiology of short bowel syndrome can be either congenital (in children) or as a result of massive surgical resections. The prevalence of SBS in Australia is not known however it is estimated there are 220 patients on home parenteral nutrition in Australia for which SBS is a major indication. Despite the low prevalence of the condition these patients are complex to manage due to chronic diarrhoea, dehydration, macro and micronutrient deficiencies and electrolyte disturbances. Many rely on home enteral or parenteral nutrition or intravenous fluid and thus have to manage the complications associated with these forms of nutrition support.
Despite medical therapy, oral rehydration solutions and a modified diet, the diarrhoea and malabsorption experienced in people with SBS is difficult to manage. This is not only debilitating but may also mean people who suffer from this condition are reliant on intravenous nutrition or hydration, therapies which are associated with a poor quality of life.

High Amylase Resistant Starch (HARS) is a form of starch that occurs naturally in food. It is available as a supplement and is frequently added to foods by the food industry to increase fibre content. HARS has no taste and is usually undetectable in food or drinks. HARS has been shown to decrease diarrhoea from a variety of causes including gastroenteritis and cholera. A pilot trial completed at Austin Health showed that adding 50g/d of HARS to the diet of people with SBS significantly reduced the total amount of diarrhoea per day and showed a trend towards a decreased number of bowel actions per day. Larger trials are needed to confirm this effect and determine if there are any improvements in the person’s ability to absorb nutrition / hydration as well as their quality of life.
We aim to recruit 50 people with SBS across Australia and supplement their diet with 50g of HARS each day for 2 months. Stool frequency and weight, urine output, body weight, handgrip strength and quality of life will be measured. The end of trial results will be compared to the participant’s baseline results (before they started taking the starch).

This study aims to determine if supplementation of HARS to the usual diet of people with short bowel syndrome will reduce the diarrhoea (frequency of bowel actions and improve stool consistency), nutrition/hydration status and quality of life.

It is hypothesized that the addition of 50g per day of HARS to the usual diet of people with short bowel syndrome will decrease the amount of diarrhea they experience and in turn improve their nutritional and hydration status as well as quality of life.

Any therapy which can improve the quality of life of an individual with a chronic potentially life threatening condition has huge implications for the individual.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80914 0
Ms Kate Hamilton
Address 80914 0
Nutrition Department
Austin Health
145 Studley Road
Heidelberg 3084
Country 80914 0
Australia
Phone 80914 0
+61394965011
Fax 80914 0
+61394963168
Email 80914 0
[email protected]
Contact person for public queries
Name 80915 0
Ms Kate Hamilton
Address 80915 0
Nutrition Department
Austin Health
145 Studley Road
Heidelberg 3084
Country 80915 0
Australia
Phone 80915 0
+61394965011
Fax 80915 0
+61394963168
Email 80915 0
[email protected]
Contact person for scientific queries
Name 80916 0
Ms Kate Hamilton
Address 80916 0
Nutrition Department
Austin Health
145 Studley Road
Heidelberg 3084
Country 80916 0
Australia
Phone 80916 0
+61394965011
Fax 80916 0
+61394963168
Email 80916 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.