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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

17/02/2022

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]

Nil known

Universal Trial Number (UTN)

U1111-1258-2864

Trial acronym

The OMG Study

Linked study record

ACTRN12620001337965 (The FIDGIT Study)
Recruits in the above study who meet the criteria for the OMG study (i.e., elevated basal gases) will be invited to participate in the OMG study. Some data collection tools used in The FIDGIT Study are identical to data being collected in the OMG Study, but will not be duplicated. Additional microbiome data will be available from FIDGIT study participants.
Some OMG study participants are not part of The FIDGIT Study.

Health condition

Health condition(s) or problem(s) studied:

Oral dysbiosis

Functional gastrointestinal disorders

Condition category

Condition code

Oral and Gastrointestinal

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) and participants in The FIDGIT Study (ACTRN12620001318976) 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 sample is collected, then mouthwash is administered as per step 3.
Step 3: a) Oral rinse with 10mL water, with instructions to swish and gargle for 20 seconds before spitting out.
b) 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. A second oral sample is also collected.
Step 4. a)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.
b) 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 sample is also collected.
Step 5: The test substrate is administered by clinic staff as ordered by the referring practitioner or according to study protocol (study record ACTRN12620001318976) (i.e., Glucose 50g, 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)
- 15 minutes following oral lactulose challenge (i.e., 13 times over 3 hours
- 15 minutes following oral fructose or lactose challenges (i.e., 13 times over 3 hours)
Oral samples 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 (NOTE that The FIDGIT Study participants [ACTRN12620001318976] complete the identical survey and do not need to repeat it in this study.
• 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]

Diagnosis / Prognosis

Comparator / control treatment

Water mouthrinse, as detailed in Step 3 a) "Description of intervention(s) / exposure*"

Control group

Active

Outcomes

Primary outcome [1]

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]

At baseline, with repeated measures every 15 minutes for up to 3 hours (as detailed in Step 3).

Primary outcome [2]

To examine the impact of water rinse and/or mouthwash on the oral microbiota. Oral samples collected upon determination of elevated basal breath gases, prior to collection of initial breath sample, and again after mouth washing with water, and after mouth washing with SalviaThymol N.

Timepoint [2]

Oral samples are collected at baseline, prior to mouth rinsing with water, within 3 minutes of said rinse being conducted and again after mouth washing with SalviaThymol N,, and within 3 minutes of the mouthwash being completed.
These changes were made after the OMG study had enrolled 29 participants.

Secondary outcome [1]

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]