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Trial registered on ANZCTR
Registration number
ACTRN12624001489583
Ethics application status
Approved
Date submitted
18/11/2024
Date registered
20/12/2024
Date last updated
20/12/2024
Date data sharing statement initially provided
20/12/2024
Date results provided
20/12/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluating a sham diet for food-based interventional trials in ulcerative colitis
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Scientific title
Evaluating a sham diet in healthy volunteers for food-based interventional trials in ulcerative colitis
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Secondary ID [1]
313404
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative colitis
335780
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Condition category
Condition code
Oral and Gastrointestinal
332354
332354
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A research dietitian will provide sham dietary advice including a 20-minute verbal dietary education, a diet manual, recipes and a comprehensive 3-day meal plan to 10-20 healthy adults. These resources have been specifically designed for this trial. The sham diet and dietary advice provided has been developed to mirror the level of complexity and appearance of the experimental diet that has been designed for future use in a randomised, placebo-controlled trial. The nutritional prescription is modelled on a typical Australian dietary intake.
Participants will be counselled during a one-on-one face-to-face consult on following the dietary advice for 7 days. Adherence to the diet will be evaluated using a 3-day weighed food diary.
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Intervention code [1]
329979
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Lifestyle
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Composite primary outcome: Therapeutic appearance and success of blinding of the sham diet
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Assessment method [1]
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Therapeutic appearance measured using binary question (yes, no, unsure) using a study-specific questionnaire and success of blinding the sham diet measured using a 5-point Likert scale asking individuals to rate how surprised they would be to discover if the diet was not a therapeutic intervention diet using a study specific questionnaire
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Timepoint [1]
339913
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End of week 1
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Secondary outcome [1]
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Dietary intake
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Assessment method [1]
441900
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3-day weighed food diary evaluated using Foodworks 10 dietary software and Monash FODMAP calculator
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Timepoint [1]
441900
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Baseline and end of week 1
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Secondary outcome [2]
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Change in bowel function
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Assessment method [2]
441898
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Binary question (yes, no, unsure) evaluated using a study specific questionnaire
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Timepoint [2]
441898
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Baseline and end of week 1
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Secondary outcome [3]
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Dietary adherence
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Assessment method [3]
441895
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Self-reported, pre-defined adherence categories (less than 25% equals never/rarely, 25-50% equals sometimes, 51-75% equals frequently, 76-100% equals always) evaluated using a study-specific questionnaire and a 3-day weighed food diary to assess adherence to key sham diet principles
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Timepoint [3]
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End of week 1
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Secondary outcome [4]
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Ease of purchasing diet
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Assessment method [4]
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100-mm visual analogue scale (0 extremely unacceptable and 100 equals extremely acceptable) to measure ease of purchase of diet. Overall acceptability is defined as a mean/median score greater than or equal to 51, using a study specific questionnaire.
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Timepoint [4]
442631
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End of week 1
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Secondary outcome [5]
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Tolerability
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Assessment method [5]
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100-mm visual analogue scale (0 equals extremely intolerable and 100 equals extremely tolerable). Tolerability is defined as a mean/median score of greater than or equal to 51 or withdrawal from study with a record or any adverse event, using a study specific questionnaire
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Timepoint [5]
441896
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End of week 1
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Secondary outcome [6]
441894
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Acceptability
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Assessment method [6]
441894
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100-mm visual analogue scale (0 extremely unacceptable and 100 equals extremely acceptable) to measure acceptability of following the diet. Overall acceptability is defined as a mean/median score greater than or equal to 51, using a study specific questionnaire
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Timepoint [6]
441894
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End of week 1
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Secondary outcome [7]
441897
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Change in stool consistency
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Assessment method [7]
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Bristol stool chart where a normal consistency stool is defined as a Type 4 stool
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Timepoint [7]
441897
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Baseline and end of week 1
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Secondary outcome [8]
442630
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Ease of preparation of diet
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Assessment method [8]
442630
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100-mm visual analogue scale (0 extremely unacceptable and 100 equals extremely acceptable) to measure ease of preparation of diet. Overall acceptability is defined as a mean/median score greater than or equal to 51, using a study specific questionnaire.
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Timepoint [8]
442630
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End of week 1
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Secondary outcome [9]
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Overall tolerability of sham diet
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Assessment method [9]
442633
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100-mm visual analogue scale (0 extremely unacceptable and 100 equals extremely acceptable) to measure overall tolerability. Overall tolerability is defined as a mean/median score greater than or equal to 51, using a study specific questionnaire.
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Timepoint [9]
442633
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End of week 1
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Secondary outcome [10]
442632
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Overall ease of following sham diet
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Assessment method [10]
442632
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100-mm visual analogue scale (0 extremely unacceptable and 100 equals extremely acceptable) to measure overall ease of following diet. Overall acceptability is defined as a mean/median score greater than or equal to 51, using a study specific questionnaire.
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Timepoint [10]
442632
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End of week 1
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Eligibility
Key inclusion criteria
Must meet all of the following criteria:
1] Healthy adults greater than or equal to 18 years of age
2] Not aware of the prescribed intervention diet
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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?
Yes
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Key exclusion criteria
If any one of the following criteria is met, healthy individuals are excluded from the study:
1] Diagnosis inflammatory bowel disease
2] Diagnosis of any other gastrointestinal condition with known dietary intervention as treatment (e.g. coeliac disease, eosinophilic esophagitis, irritable bowel syndrome)
3] Pregnant or breastfeeding
4] Significant medical comorbidities that require a therapeutic diet
5] Significant cognitive/psychiatric conditions
6] Prior gastrointestinal surgery
7] Taking medications known to alter bowel function
8] Evidence of active infection and/or those requiring current antibiotic therapy
9] Habitually following a vegan or vegetarian diet
10] Habitually following a popularised diet for perceived health or weight loss benefits
11] Unable to provide informed consent
12] Enrolled in any other trial
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
3/03/2021
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Date of last participant enrolment
Anticipated
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Actual
21/07/2021
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Date of last data collection
Anticipated
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Actual
29/07/2021
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Sample size
Target
12
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
317846
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Charities/Societies/Foundations
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Name [1]
317846
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The Hospital Research Foundation Project Grant
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Address [1]
317846
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Country [1]
317846
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Australia
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Primary sponsor type
Hospital
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Name
The Queen Elizabeth Hospital, Central Adelaide Local Health Network
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Address
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of Adelaide
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Address [1]
320176
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Country [1]
320176
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316527
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
316527
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
316527
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Australia
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Date submitted for ethics approval [1]
316527
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01/07/2020
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Approval date [1]
316527
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15/10/2020
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Ethics approval number [1]
316527
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Summary
Brief summary
This study aims to investigate the therapeutic appearance, nutritional content and participant acceptability of a sham dietary prescription in healthy individuals. The intent of the sham diet is to have the appearance of a therapeutic diet by excluding or substituting inert food items without altering overall nutrient intake compared to habitual diet. The sham diet has been designed for future use in placebo-controlled dietary advice trials for ulcerative colitis.
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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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Dr Alice Day
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Address
138166
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Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
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Country
138166
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Australia
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Phone
138166
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+61 413550112
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Fax
138166
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Email
138166
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[email protected]
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Contact person for public queries
Name
138167
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Alice Day
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Address
138167
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Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
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Country
138167
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Australia
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Phone
138167
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+61 8 8222 6486
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Fax
138167
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Email
138167
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[email protected]
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Contact person for scientific queries
Name
138168
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Alice Day
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Address
138168
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Department of Gastroenterology, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, South Australia 5011
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Country
138168
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Australia
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Phone
138168
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+61 413550112
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Fax
138168
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Email
138168
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Not required
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Conference abstract
Yes
https://doi.org/10.1111/jgh.15957
Abstract 149
Documents added automatically
No additional documents have been identified.
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