Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000153819
Ethics application status
Approved
Date submitted
3/11/2020
Date registered
15/02/2021
Date last updated
15/02/2021
Date data sharing statement initially provided
15/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effect of dietary strategies on gastrointestinal symptoms associated with endometriosis
Scientific title
Creating an evidence base for clinical care: A randomised controlled study examining the efficacy of dietary therapy for the relief of gastrointestinal symptoms in endometriosis
Secondary ID [1] 302638 0
None
Universal Trial Number (UTN)
U1111-1260-5146
Trial acronym
ENDO-DIET study
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
endometriosis with gut symptoms 319536 0
Condition category
Condition code
Reproductive Health and Childbirth 317487 317487 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with a low Fermentable Oligosaccharide Disaccharide, Monosaccharide and Polyols (FODMAP) diet for a month, and a high FODMAP, or typical Australian diet for a month. They will be randomized to receive which diet first. Participants won't be told that it involves FODMAPs as many will not be naive. By naïve we mean those not familiar with this diet as it is very popular in people with gut symptoms. Both diets are very similar in composition.
The control diet is a typical Australian diet. The intervention is the low FODMAP diet.
The low FODMAP diet will be similar in design to the typical Australian diet, both being cooked by professional chefs experienced in this area. Examples of meals provided to look like a typical Australian diet in both diets are lasgna, spaghetti Bolognese, where the pasta is either gluten free making it low FODMAP, or normal, which is high FODMAP. there will be no onion or garlic in the low FODMAP diet. Another is a chicken cacciatore, where in one diet there will be no onion, and in the other, onion. Weetbix and bread will be supplied, which is again attainable as being either low or high FODMAP. Drink examples are apple juice,(high FODMAP) vs black currant (low FODMAP). recommended fruit snacks will be either apple, pear, stone fruit (high FODMAP) or berries, bananas, oranges (low) The low FODMAP diet avoids the use of certain fermentable fibres such as onion, garlic, high fructose containing fruits such as apples, pears, and other high fructans containing food. Lactose free milk will be provided, but participants will not know which is which.

Their involvement is for 3 months with a 1 week baseline food diary and symptom collection before commencing the first diet.
Then follows a month off where they can eat what they want as a wash out period. The second diet will then be brought to them for the 3rd month.
A daily food diary will be kept to check for adherence. At the end of the months of study food a questionnaire is completed, and a stool and vaginal swab collected that the participant would have been asked to collect, including instructions and storage. They will be visited at the end of both months to collect the diary, questionnaire and biological samples.
The instructions for involvement will be given at recruitment by both the study doctor and the coordinator where prior to consent a detailed description of the study is given. The study coordinator will be in contact at least weekly to check all is OK. The contact number of the dietitian involved will be given for any queries over food as the coordinator is blinded as to what food the participant is eating.
Intervention code [1] 318930 0
Lifestyle
Intervention code [2] 319320 0
Treatment: Other
Comparator / control treatment
The control diet is a typical Australian diet. This is considered relatively high in FODMAPs if certain foods are not avoided. Examples of what is considered a typical Australian diet includes Spaghetti Bolognese, chicken cacciatore, casseroles. These foods would include onion and garlic, other fruit and vegetables that are high in FODMAP content such as apples, pears, asparagus, and foods containing wheat such as weetbix and bread.
Control group
Active

Outcomes
Primary outcome [1] 325524 0
Composite measure: a decrease of >20 mm of VAS score compared to baseline score, and/or VAS of <30mm at conclusion of interventions as compared to baseline VAS score pre commencing diet.
Timepoint [1] 325524 0
conclusion of both diets
Secondary outcome [1] 388280 0
A change in gastrointestinal symptoms which include abdominal bloating, abdominal pain, wind, satisfaction with stool consistency, tiredness and lethargy, nausea, and stool type as per the Bristol stool scale.

This will be via a composite group of validated questionnaires, such as the gastrointestinal quality of life (GIQLI), endometriosis health profile questionnaire (EHP), and the NIH, PROMIS GI symptoms scale
Timepoint [1] 388280 0
At the end of both diets
Secondary outcome [2] 388281 0
A change in Quality of life and psychological status. This is part of a composite questionnaire as described above
The GIQLI questionnaire is used to capture this
Timepoint [2] 388281 0
At the end of the 2 diets
Secondary outcome [3] 388285 0
We are looking to see if there is a change in microbiota from stool and vaginal swab collected at the end of both dietary periods as compared with the run in period pre study.
This is an exploratory outcome.
Timepoint [3] 388285 0
at the end the one week run in and at the end of each diet

Eligibility
Key inclusion criteria
Women with diagnosed endometriosis experiencing gastrointestinal symptoms with a mean VAS symptom score >30mm at baseline
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent laparoscopic surgery in last 3 months, coeliac disease, other GI disease, e.g. Crohns disease, had a hysterectomy, or removal of ovaries, major bowel resection, known food allergy, malnutrition, active psychological illness

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)
central randomisation via computer allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence allocation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size of 24 sufficient to detect a change in overall gastrointestinal symptoms. Calculation based on data from previous studies in our department. Assuming drop out rate of 30% total of 32 need to be recruited. Comparisons of measured end points assessed by one way ANOVA, post hoc comparisons using Bonferroni's correction. Bioinformatics conducted at UQ, microbiome and bioinformatics data analyses performed by Prof Morrison

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/12/2020
Date of last participant enrolment
Anticipated
1/12/2022
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
32
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17904 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 31765 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 307069 0
Government body
Name [1] 307069 0
NHMRC
Country [1] 307069 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Dept Gastroenterology, level 6, The Alfred Centre, 99 Commercial Rd, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 307687 0
None
Name [1] 307687 0
Address [1] 307687 0
Country [1] 307687 0
Other collaborator category [1] 281519 0
Charities/Societies/Foundations
Name [1] 281519 0
Endometriosis Australia
Address [1] 281519 0

Endometriosis Australia
C/O Weston, Woodley & Robertson
PO Box 1070
North Sydney
NSW 2059
Country [1] 281519 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307193 0
Monash Ethics Research Committee
Ethics committee address [1] 307193 0
Ethics committee country [1] 307193 0
Australia
Date submitted for ethics approval [1] 307193 0
14/08/2020
Approval date [1] 307193 0
19/10/2020
Ethics approval number [1] 307193 0
25358

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106354 0
Dr Judith Moore
Address 106354 0
Monash Dept Gastroenterology,
Level 6
The Alfred Centre
99 Commercial Rd
Melbourne 3004
VIC
Country 106354 0
Australia
Phone 106354 0
+61 3 99030233
Fax 106354 0
Email 106354 0
[email protected]
Contact person for public queries
Name 106355 0
Judith Moore
Address 106355 0
Monash Dept Gastroenterology,
Level 6
The Alfred Centre
99 Commercial Rd
Melbourne 3004
VIC
Country 106355 0
Australia
Phone 106355 0
+61 3 99030233
Fax 106355 0
Email 106355 0
[email protected]
Contact person for scientific queries
Name 106356 0
Rebecca Burgell
Address 106356 0
Monash Dept Gastroenterology,
Level 6
The Alfred Centre
99 Commercial Rd
Melbourne 3004
VIC
Country 106356 0
Australia
Phone 106356 0
+61 3 99030233
Fax 106356 0
Email 106356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD for the purposes of this study only. Access to this data is to the chief investigators and study coordinator only


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9593Study protocol    380824-(Uploaded-02-11-2020-12-15-00)-Study-related document.pdf
9594Informed consent form    380824-(Uploaded-18-01-2021-12-59-02)-Study-related document.pdf
9595Ethical approval    380824-(Uploaded-02-11-2020-12-16-05)-Study-related document.pdf



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.