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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]

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

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

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]

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]

Quality of life (as measured by EQD5

Timepoint [2]

Quality of life is measured on enrollment (day 0) of the trial and on completion of the trial (day 90)

Primary outcome [3]

Handgrip strength (measured via dynamometer)

Timepoint [3]

Handgrip strength will be collected on enrollement into the trial (day 0) and on completion of the trial (day 90)

Secondary outcome [1]

Stool frequency (number of bowel actions per day). Participants will record each bowel motion in a participant diary.

Timepoint [1]

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]

Stool consistency (measured in type as per the Bristol Stool Chart

Timepoint [2]

On 2 days per week of the control and intervention periods

Secondary outcome [3]

Nutritional markers (weight, mid upper arm circumference)

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [3]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [4]

The Canberra Hospital - Garran

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

2050 - Camperdown

Recruitment postcode(s) [3]

4029 - Herston

Recruitment postcode(s) [4]

2605 - Garran

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Austin Health Medical Research Foundation
145 Studley Road
Heidleberg 3084

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Austin Health Human Research Ethics Comittee

Ethics committee address [1]

Austin Health HREC
145 Studley Road
Heidleberg 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/02/2018

Approval date [1]

Ethics approval number [1]

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

Ms Kate Hamilton

Address

Nutrition Department
Austin Health
145 Studley Road
Heidelberg 3084

Country

Australia

Phone

+61394965011

Fax

+61394963168

[email protected]

Contact person for public queries

Name

Kate Hamilton

Address

Nutrition Department
Austin Health
145 Studley Road
Heidelberg 3084

Country

Australia

Phone

+61394965011

Fax

+61394963168

[email protected]

Contact person for scientific queries

Name

Kate Hamilton

Address

Nutrition Department
Austin Health
145 Studley Road
Heidelberg 3084

Country

Australia

Phone

+61394965011

Fax

+61394963168

[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

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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