ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

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

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]

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]

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]

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]

Number of daily bowel actions recorded daily by the participant in the participant diary

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

145 Studley road
Heidelberg 3084
Victoria

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley road
Heidelberg 3084
Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley road
Heidelberg 3084
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/02/2013

Approval date [1]

07/04/2013

Ethics approval number [1]

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

Ms Kate Hamilton

Address

Nutrition Department, Austin Health
145 Studley road
Heidelberg 3084
Victoria

Country

Australia

Phone

61 03 9496 5011

Fax

61 03 94963168

kate.hamilton2@austin.org.au

Contact person for public queries

Name

Kate Hamilton

Address

Nutrition Department, Austin Health
145 Studley road
Heidelberg 3084
Victoria

Country

Australia

Phone

61 03 9496 5011

Fax

61 03 9496 3168

kate.hamilton2@austin.org.au

Contact person for scientific queries

Name

Kate Hamilton

Address

Nutrition Department, Austin Health
145 Studley road
Heidelberg 3084
Victoria

Country

Australia

Phone

61 03 9496 5011

Fax

61 03 9496 3168

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

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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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