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Trial registered on ANZCTR
Registration number
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?
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Scientific title
Does the consumption of marshmallows reduce the stoma output for patients with ileostomies?
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Secondary ID [1]
282601
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
Nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stoma output
289295
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Patients with ileostomies
289301
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Condition category
Condition code
Surgery
289623
289623
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
287270
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Treatment: Other
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Comparator / control treatment
Active control (cross-over trial)- no treatment or marshmallow free diet for 5 days
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Control group
Active
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Outcomes
Primary outcome [1]
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Mean daily stoma output as measured in millilitres per day and recorded by participants on record sheets provided.
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [1]
303070
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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.
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Assessment method [1]
303070
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Timepoint [1]
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After 5 days of intervention and after 5 days of control
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/06/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
1071
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment postcode(s) [1]
6931
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3220 - Geelong
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Department of Surgery, Deakin University
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Address [1]
287382
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The Geelong Hospital. Corner Ryrie St. Geelong
VIC 3220
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Country [1]
287382
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
Department of Surgery, Deakin University. The Geelong Hospital. Corner Ryrie St. Geelong
VIC 3220
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Country
Australia
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Secondary sponsor category [1]
286129
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None
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Name [1]
286129
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Address [1]
286129
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Country [1]
286129
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
289356
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Human Research Ethics Committee - Geelong Hospital
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Ethics committee address [1]
289356
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Geelong Hospital. Ryrie Street Geelong
VIC 3220
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Ethics committee country [1]
289356
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Australia
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Date submitted for ethics approval [1]
289356
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21/05/2013
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Approval date [1]
289356
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Ethics approval number [1]
289356
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13-56-RRC
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Douglas Stupart
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Address
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Department of Surgery, The Geelong Hospital.
Ryrie St Geelong. VIC 3220
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Country
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Australia
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Phone
40450
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+613 42152001
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Fax
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Email
40450
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[email protected]
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Contact person for public queries
Name
40451
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Mr Douglas Stupart
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Address
40451
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Department of Surgery, The Geelong Hospital.
Ryrie St Geelong. VIC 3220
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Country
40451
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Australia
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Phone
40451
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+613 42152001
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Fax
40451
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Email
40451
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[email protected]
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Contact person for scientific queries
Name
40452
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Mr Douglas Stupart
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Address
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Department of Surgery, The Geelong Hospital.
Ryrie St Geelong. VIC 3220
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Country
40452
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Australia
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Phone
40452
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+613 42152001
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Fax
40452
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Email
40452
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[email protected]
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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.
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