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Trial registered on ANZCTR


Registration number
ACTRN12620001318976
Ethics application status
Approved
Date submitted
28/09/2020
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The OMG Study: An investigation into the relationship between the Oral Microbiome and Gut Function in adults.
Scientific title
Assessing:the oral microbiome and the impact of an essential-oil based mouthwash on the levels of expired hydrogen and methane in adults presenting with gastrointestinal dysfunction.
Secondary ID [1] 302640 0
Nil known
Universal Trial Number (UTN)
U1111-1258-2864
Trial acronym
The OMG Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral dysbiosis 319129 0
Functional gastrointestinal disorders 319130 0
Condition category
Condition code
Oral and Gastrointestinal 317093 317093 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All adults who are referred for hydrogen-methane breath testing (regardless of the type of breath test to be conducted) who have elevated basal breath gases are potential candidates for inclusion.
Step 1: Three breath samples are collected from each participant within a 3-minute period and analysed within 5 minutes. The average value determines the baselines gas value.
Step 2: Where the calculated value in step 1 is 10ppm or more, an oral swab is collected, then mouthwash is administered as per step 3.
Step 3: 10mL of 1% solution of an essential-oil based mouthwash (SalviaThymol N, which contains 2mg sage oil, 2mg eucalyptus oil, 23mg peppermint oil, 2mg cinnamon oil, 5mg clove oil, 10mg fennel oil, 5mg star anise oil, 20mg l-menthol and 1mg thymol per gram) is administered, under supervision of clinic staff, with instructions to swish and gargle for 20 seconds before spitting out.
Step 4: Three breath further samples will then be collected within a 3-minute period and analysed within 5 minutes. The average of these utilised to calculate changes from the value calculated at Step 1. An oral swab is also collected.
Step 5: The test substrate is administered by clinic staff as ordered by the referring practitioner (i.e., Glucose 75g, lactulose 10g, lactose 25g or fructose 25g).
Step 6: Participants who meet the predetermined levels of expired hydrogen and/or methane following the first SalviaThymol mouthwash are allocated to the protocol, whereby at each subsequent time-point during the breath testing period, a single breath sample will be collected, followed by a SalviaThymol mouthwash and a further breath sample. Thus, the SalviaThymol mouthwash will be repeated at the following intervals:
- 15 minutes following oral glucose challenge (i.e., 11 times over 2.5hrs)
- 20 minutes following oral lactulose challenge (i.e., 11 times over 3 hours
- 30 minutes following oral fructose or lactose challenges (i.e., 7 times over 3 hours)
Oral swabs are for 16s rRNA or shotgun metagenomic analysis.
The mouthwash and breath samples are administered and collected by employees of the breath testing facility, who are Registered Naturopaths or Nutritionists, trained by, and under the supervision of the clinic director who is the study co-ordinator (Registered Nurse, Registered Nutritionist, PhD candidate)
All participants will complete an online questionnaire which merges the following tools:
• ACR 2016 (Wolfe et al. 2016)
• Revised Fibromyalgia Impact Questionnaire (FIQR) (Bennett et al. 2009; Burckhardt, Clark, and Bennett 1991)
• Rome IV (Drossman and Hasler 2016; Palsson et al. 2016)
• Functional Bowel Disorder Severity Index (FBDSI) (Drossman et al. 1995; Sperber et al. 2000)
• Headache Symptom Questionnaire (HSQ) (van der Meer et al. 2019; (IHS) 2013)
• Medical Outcomes Study Sleep Scale (SSS) (Williams and Arnold 2011)
• Short Form Survey -36 (SF36) (McHorney et al. 1994; Hays, Sherbourne, and Mazel 1995)
• Oral Health Questionnaire (OHQ) (Petersen, Baez, and World Health 2013)
Intervention code [1] 318934 0
Diagnosis / Prognosis
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325178 0
To determine if elevated breath hydrogen and/or methane may be modified by an essential oil-based mouthwash.
Instruments used:
Hydrogen-methane breath testing, samples collected before and after mouthwash in participants with elevated basal alveolar breath gases. "Elevated" defined as either hydrogen or methane gas >9ppm of end expiratory breath.
Timepoint [1] 325178 0
At baseline, with repeated measures every 15, 20 or 30 minutes for up to 3 hours (as detailed in Step 3).
Primary outcome [2] 325179 0
To identify the oral flora impacted by the mouthwash.
Oral swabs collected upon determination of elevated basal breath gases, prior to collection of initial breath sample, and again after mouth washing with SalviaThymol N.
Timepoint [2] 325179 0
Oral swabs are collected at baseline, prior to mouth washing with SalviaThymol N,, and within 3 minutes of the mouthwash being completed.
Secondary outcome [1] 387101 0
Assess symptoms consistent with fibromyalgia as per the ACR 2016 (Wolfe et al. 2016) & Revised Fibromyalgia Impact Questionnaire (FIQR) (Bennett et al. 2009; Burckhardt, Clark, and Bennett 1991)
Timepoint [1] 387101 0
At baseline, within 7 days of breath testing. Participants will be provided internet access to enable completion of the integrated questionnaire while attending the breath testing session.
Secondary outcome [2] 387103 0
Assess symptoms associated with functional gastrointestinal disorders as per Rome IV (Drossman and Hasler 2016; Palsson et al. 2016) and the Functional Bowel Disorder Severity Index (FBDSI) (Drossman et al. 1995; Sperber et al. 2000)
Data collected using REDCap.
Timepoint [2] 387103 0
At baseline, within 7 days of breath testing. Participants will be provided internet access to enable completion of the integrated questionnaire while attending the breath testing session.
Secondary outcome [3] 388297 0
Assess oral health as per the Oral Health Questionnaire (OHQ) (Petersen, Baez, and World Health 2013)
Timepoint [3] 388297 0
At baseline, within 7 days of breath testing. Participants will be provided internet access to enable completion of the integrated questionnaire while attending the breath testing session.
Secondary outcome [4] 388298 0
Assess headaches as per the Headache Symptom Questionnaire (HSQ) (van der Meer et al. 2019; (IHS) 2013)
Data collected via integrated questionnaire on REDCap.
Timepoint [4] 388298 0
At baseline, within 7 days of breath testing. Participants will be provided internet access to enable completion of the integrated questionnaire while attending the breath testing session.
Secondary outcome [5] 389404 0
Assess sleep quality as per the Medical Outcomes Study Sleep Scale (SSS) (Williams and Arnold 2011)
Data collected via integrated questionnaire on REDCap.
Timepoint [5] 389404 0
At baseline, within 7 days of breath testing. Participants will be provided internet access to enable completion of the integrated questionnaire while attending the breath testing session.
Secondary outcome [6] 389405 0
Assess symptoms related to quality of life as per the Short Form Survey -36 (SF36) (McHorney et al. 1994; Hays, Sherbourne, and Mazel 1995)
Data collected via integrated questionnaire on REDCap.
Timepoint [6] 389405 0
At baseline, within 7 days of breath testing. Participants will be provided internet access to enable completion of the integrated questionnaire while attending the breath testing session.

Eligibility
Key inclusion criteria
Adults presenting for hydrogen-methane breath testing at House of Health (Auckland, NZ) who have
- prepared for the test as per the guidelines (standard protocol).
- elevated basal hydrogen or methane gas (defined at > 9ppm) on end expiratory alveolar breath
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- those unable to fast (water permitted) for 15 hours
- unable to give consent or complete questionnaires in English
- unwilling to have biological samples sent overseas, where the data may be included in an international databank.
- current smokers

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
From 400 people presenting for breath testing, we expect up 33% to have elevated basal gases. Rolling recruitment will continue until at least 67 participants meeting inclusion criterai have been enrolled - the number included in our previous study, which demonstrated an oral mouthwash reduced breath gases in some participants (Erdrich, et al., 2020. Under review).
Deidentified pre- and post-mouth wash test data will be entered into a Microsoft Excel spreadsheet and analysed using SPSS. Data from oral microbiome testing will be deidentified, entered into a Microsoft Excel spreadsheet and analysed using SPSS.
Deidentified data downloaded from REDCap and tabulated into spreadsheets, along with results from all test procedures. Data will then be uploaded to SPSS for analysis of clinical variables to test data utilising Spearman's Rho.
Correlations, students paired T-test, Cochrane’s Q and McNemars tests will evaluate the effect of mouthwash on diagnosis according to a range of definitions commonly used for evaluating results of hydrogen-methane breath testing.
Anthropometrics, symptom prevalance, scores & co-morbidities compared using ANOVA (univariate) & MANOVA (multivariate). For oral microbiome analyses:correction for multiple comparisons (eg using Benjamini–Hochberg FDR) and normalised operational taxonomy units (OTUs) evaluated using Pearson's correlations. Strength of associations with clinical variables tested using Spearman's Rho. .

Recruitment
Recruitment status
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 outside Australia
Country [1] 22998 0
New Zealand
State/province [1] 22998 0
Auckland

Funding & Sponsors
Funding source category [1] 306784 0
Commercial sector/Industry
Name [1] 306784 0
QuinTron Instrument Company
Address [1] 306784 0
2208 South 38th St
Milwaukee, WI 53215
Country [1] 306784 0
United States of America
Funding source category [2] 306787 0
Commercial sector/Industry
Name [2] 306787 0
House of Health Ltd
Address [2] 306787 0
888 New North Road
Mt Albert
Auckland 1025
Country [2] 306787 0
New Zealand
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Medicine and Health
The University of Sydney
NSW 2006
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 307335 0
None
Name [1] 307335 0
Address [1] 307335 0
Country [1] 307335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306945 0
Health & Disability Ethics Committee
Ethics committee address [1] 306945 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 306945 0
New Zealand
Date submitted for ethics approval [1] 306945 0
19/08/2020
Approval date [1] 306945 0
09/11/2020
Ethics approval number [1] 306945 0
20/NTB/209

Summary
Brief summary
A survey of practices related to breath testing (a foundational test for this study), revealed inconsistencies in the way hydrogen-methane breath testing is conducted globally (1). A further study by our group has demonstrated that oral hygiene practices can affect test results which has implications for diagnosis and subsequent treatment (2). It is also possible that such modifiable elevations are associated with gastrointestinal dysfunction. It also suggests a contribution from oral bacteria to expired breath gases, which has not previously been explored. A basal mouthwash is standard practice in some testing facilities. Our previous research (using chlorhexidine mouthwash) has demonstrated that this may modify the diagnosis (2). We aim to verify if these results can be duplicated utilising an essential oil-based mouthwash and determine if there are correlations between such modifiable breath gases and functional gastrointestinal disorders.
(1) Erdrich S, et al. Adv Integr Med 2020; In press. DOI: 10.1016/j.aimed.2020.03.003.
(2) Erdrich S, et al. [in press] 2020.
HYPOTHESIS
Expired hydrogen and methane gases may be modified by a mouthwash utilising an essential oil-based product in a similar manner to chlorhexidine, implying bacterial metabolism in the oral cavity. Modifiable concentrations of elevated gases are associated with functional gastrointestinal disorders.

Ethical approval has been obtained, HDEC reference 20/NTB/209
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105538 0
Dr Joanna Harnett
Address 105538 0
The University of Sydney School of Pharmacy
Faculty of Medicine and Health
The University of Sydney
NSW 2006
Country 105538 0
Australia
Phone 105538 0
+61 2 9351 7009
Fax 105538 0
+61 2 9036 0000
Email 105538 0
joanna.harnett@sydney.edu.au
Contact person for public queries
Name 105539 0
Mrs Sharon Erdrich
Address 105539 0
House of Health
888 New North Road
Mt Albert
Auckland 1025
Country 105539 0
New Zealand
Phone 105539 0
+64 9 846 5566
Fax 105539 0
+64 9 846 5567
Email 105539 0
sharon.erdrich@sydney.edu.au
Contact person for scientific queries
Name 105540 0
Mrs Sharon Erdrich
Address 105540 0
House of Health
888 New North Road
Mt Albert
Auckland 1025
Country 105540 0
New Zealand
Phone 105540 0
+64 9 846 5566
Fax 105540 0
+64 9 846 5567
Email 105540 0
sharon.erdrich@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analysed as a cohort. Accordingly, individual participant data will not be available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results