The OMG Study: An investigation into the relationship between the Oral Microbiome and Gut Function in adults.

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)