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Trial registered on ANZCTR


Trial ID
ACTRN12613000633785
Ethics application status
Not yet submitted
Date submitted
30/05/2013
Date registered
5/06/2013
Date last updated
5/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the consumption of marshmallows reduce the stoma output for patients with ileostomies?
Scientific title
Does the consumption of marshmallows reduce the stoma output for patients with ileostomies?
Secondary ID [1] 282601 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stoma output 289295 0
Patients with ileostomies 289301 0
Condition category
Condition code
Surgery 289623 289623 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover trial. Participants will consume 3 marshmallows, 3 times per day (9 marshmallows in total) for 5 days and complete another 5 days with a marshmallow free diet. There will be a 2 day washout period.
Intervention code [1] 287270 0
Treatment: Other
Comparator / control treatment
Active control (cross-over trial)- no treatment or marshmallow free diet for 5 days
Control group
Active

Outcomes
Primary outcome [1] 289710 0
Mean daily stoma output as measured in millilitres per day and recorded by participants on record sheets provided.
Timepoint [1] 289710 0
The outcome will be measured at 2 time points. Measurements will be self recorded by patients on a record sheet provided which will be sent back to researchers in reply paid envelopes after the 5 days of intervention and again after the 5 days of control.
Secondary outcome [1] 303070 0
Mean frequency of stoma bag changes per day. The daily number of stoma bag changes will be self recorded by patients on a record sheet provided which will be sent back to researchers in reply paid envelopes after the 5 days of intervention and again after the 5 days of control to determine the mean frequency of stoma bag changes per day.
Timepoint [1] 303070 0
After 5 days of intervention and after 5 days of control

Eligibility
Key inclusion criteria
1. Received permanent or temporary ileostomy at least 3 months ago
2. Age over 18 years
3. Consent received by principle investigator
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A planned or actual change in medications (including motility agents or steroids) over the study period as reported by patient or new medication started less than 2 weeks before trial commencement
2. Illness requiring hospitalization or change in underlying disease that would effect stoma output and necessitate change in medications during trial period (eg. flare of underlying Crohn’s disease)
3. A medical condition (including diabetes) that precludes the intake of marshmallows
4. Dietary restriction of gelatine

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Power calculation: The mean output from an established ileostomy is 465ml (S.D 219). We regard a clinically relevant reduction in output to be 150ml.
For an alpha level of 0.05 and beta of 0.1, we would require 23 patients (calculated for paired samples). Calculation done using Medcalc (R) software.
We will aim to recruit 40 patients to account for drop out.

Student t-test will be used for statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1071 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 6931 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 287382 0
University
Name [1] 287382 0
Department of Surgery, Deakin University
Address [1] 287382 0
The Geelong Hospital. Corner Ryrie St. Geelong
VIC 3220
Country [1] 287382 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Department of Surgery, Deakin University. The Geelong Hospital. Corner Ryrie St. Geelong
VIC 3220
Country
Australia
Secondary sponsor category [1] 286129 0
None
Name [1] 286129 0
Address [1] 286129 0
Country [1] 286129 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289356 0
Human Research Ethics Committee - Geelong Hospital
Ethics committee address [1] 289356 0
Geelong Hospital. Ryrie Street Geelong
VIC 3220
Ethics committee country [1] 289356 0
Australia
Date submitted for ethics approval [1] 289356 0
21/05/2013
Approval date [1] 289356 0
Ethics approval number [1] 289356 0
13-56-RRC

Summary
Brief summary
The aim of the trial is to find out whether eating marshmallows helps to reduce the stoma output in people with an ileostomy. Eating marshmallows to reduce stoma output is widely documented on online websites and blogs as well as in the recommendations given by stoma-care therapists. However, there is no evidence to support these recommendations.
We will invite people that have had an ileostomy for at least 3 months, are medically stable, with no relevant dietary restrictions and over 18 years of age to take part in the trial.

We will use a repeated measures design with random crossover between a 5 day study period and 5 day control period with a 2 day ‘wash out’ in between.

Primary outcome: to determine the efficacy of marshmallow intake in reducing stoma output in patients with ileostomies.
Hypotheses:
a) Marshmallow in take will reduce daily stoma output volumes
b) Marshmallow intake will reduce the frequency of daily stoma bag empties and changes

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40450 0
Mr Douglas Stupart
Address 40450 0
Department of Surgery, The Geelong Hospital.
Ryrie St Geelong. VIC 3220
Country 40450 0
Australia
Phone 40450 0
+613 42152001
Fax 40450 0
Email 40450 0
douglasstupart@yahoo.co.uk
Contact person for public queries
Name 40451 0
Mr Douglas Stupart
Address 40451 0
Department of Surgery, The Geelong Hospital.
Ryrie St Geelong. VIC 3220
Country 40451 0
Australia
Phone 40451 0
+613 42152001
Fax 40451 0
Email 40451 0
douglasstupart@yahoo.co.uk
Contact person for scientific queries
Name 40452 0
Mr Douglas Stupart
Address 40452 0
Department of Surgery, The Geelong Hospital.
Ryrie St Geelong. VIC 3220
Country 40452 0
Australia
Phone 40452 0
+613 42152001
Fax 40452 0
Email 40452 0
douglasstupart@yahoo.co.uk