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Trial registered on ANZCTR


Registration number
ACTRN12624001402538
Ethics application status
Approved
Date submitted
11/11/2024
Date registered
26/11/2024
Date last updated
26/11/2024
Date data sharing statement initially provided
26/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Endo Gut Study - Understanding the prevalence, type and frequency of gastrointestinal symptoms in women with and without endometriosis.
Scientific title
Prevalence, type and frequency of gastrointestinal symptoms in women with and without endometriosis - Role of psychological distress and comparison of stool and vaginal microbiota in these women
Secondary ID [1] 312604 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 335703 0
Irritable bowel syndrome 335704 0
Condition category
Condition code
Reproductive Health and Childbirth 332271 332271 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There is a high prevalence of gut symptoms in the endometriosis population where a concurrent diagnosis of irritable bowel syndrome (IBS) is common. As symptoms in women with or without endometriosis are similar it is often difficult distinguishing between endometriosis and IBS. We want to know if IBS in this setting is a true co-morbidity or a misdiagnosis. To do this we will examine differences in the stool and vaginal microbiota, psychological distress and clinical phenotypes of women with endometriosis compared to those with endometriosis excluded via laparoscopy and healthy controls.

For participants, this involves collecting one-off stool and vaginal swab samples at home on the same day completing several one-off questionnaires (e.g. Bristol stool chart, ENDOMETRIOSIS HEALTH PROFILE QUESTIONNIRE, NIH PROMIS GI symptom scale, gastrointestinal quality of life (GIQLI) questionnaire, Depression and Anxiety Symptom Score (DASS21).
These data collection tools will provide information about the gastrointestinal symptoms, psychological status and faecal + vaginal microbiota of study participants.
Completing the questionnaires will take participants approximately 30 mins and collecting the stool and vaginal swab will take approximately 10 mins.
Participants will complete the study once they collect the samples and completed the questionnaires on one day.

Intervention code [1] 329933 0
Not applicable
Comparator / control treatment
People with gastrointestinal symptoms who have had endometriosis ruled out via laparoscopy and heathy controls. The reference control group will be people with gastrointestinal symptoms who have had endometriosis ruled out via laparoscopy.
Control group
Active

Outcomes
Primary outcome [1] 339842 0
Differences in microbiota profile
Timepoint [1] 339842 0
One-off assessment - cross-sectional data
Secondary outcome [1] 441618 0
Prevalence of IBS
Timepoint [1] 441618 0
One-off assessment - cross-sectional data
Secondary outcome [2] 441619 0
Stool characteristics - this will be assessed as a composite outcome
Timepoint [2] 441619 0
One-off assessment - cross-sectional data
Secondary outcome [3] 441621 0
Quality of life
Timepoint [3] 441621 0
One-off assessment - cross-sectional data
Secondary outcome [4] 441622 0
Psychological distress
Timepoint [4] 441622 0
One-off assessment - cross-sectional data
Secondary outcome [5] 441934 0
Bloating
Timepoint [5] 441934 0
One-off assessment - cross-sectional data
Secondary outcome [6] 441935 0
Diarrhoea
Timepoint [6] 441935 0
one-off assessment - cross-sectional data
Secondary outcome [7] 441936 0
Constipation
Timepoint [7] 441936 0
one off assessment
Secondary outcome [8] 441937 0
Bloating
Timepoint [8] 441937 0
one-off assessment
Secondary outcome [9] 441938 0
Abdominal pain
Timepoint [9] 441938 0
one-off assessment
Secondary outcome [10] 441939 0
disrupted swallowing
Timepoint [10] 441939 0
one-off assessment
Secondary outcome [11] 441940 0
nausea
Timepoint [11] 441940 0
one-off assessment

Eligibility
Key inclusion criteria
Group 1 - People diagnosed with endometriosis either by laparoscopy or imaging studies, and experiencing gut symptoms, e.g. IBS
Group 2 - People who have been investigated via laparoscopy but no endometriosis found, and are experiencing gut symptoms e.g. IBS
Group 3 - healthy controls, no endometriosis and no gut symptoms
Minimum age
19 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anitbiotics or probiotics within the month before participating.
Known inflammatory bowel disease / symptoms
GI malignancy
Past bowel resection
Pregnancy or breast feeding

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/03/2022
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
124
Accrual to date
114
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317033 0
Government body
Name [1] 317033 0
Australian Government Department of Health and Aged Care: Medical Research Future Fund
Country [1] 317033 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 319280 0
None
Name [1] 319280 0
Address [1] 319280 0
Country [1] 319280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315789 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315789 0
Ethics committee country [1] 315789 0
Australia
Date submitted for ethics approval [1] 315789 0
26/10/2020
Approval date [1] 315789 0
10/11/2020
Ethics approval number [1] 315789 0
26636

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

Contacts
Principal investigator
Name 135798 0
A/Prof Jane Muir
Address 135798 0
Monash University, 99 Commercial Rd, Melbourne, VIC 3004
Country 135798 0
Australia
Phone 135798 0
+61 03 9903 0274
Fax 135798 0
Email 135798 0
jane.muir@monash.edu
Contact person for public queries
Name 135799 0
Jane Varney
Address 135799 0
Monash University, 99 Commercial Rd, Melbourne, VIC 3004
Country 135799 0
Australia
Phone 135799 0
+61 03 9903 3615
Fax 135799 0
Email 135799 0
jane.varney@monash.edu
Contact person for scientific queries
Name 135800 0
Jane Muir
Address 135800 0
Monash University, 99 Commercial Rd, Melbourne, VIC 3004
Country 135800 0
Australia
Phone 135800 0
+61 9903 3615
Fax 135800 0
Email 135800 0
jane.varney@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not agreed to do this


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.