None listed
Conditions
Brief summary
In summary, the main aim of this study is to investigate the drug concentration of routine peri-operative care medication (antibiotics and oral steroids) in the nasal mucus and stool in relation to changes in the nasal and gut microbiome respectively. We anticipate that better understanding of the effects of our current medical management, including their adverse effects, will help in the future to develop and deliver more targeted therapy to our patients. Study Aims The overall goal of this study is to extend our previous research in the effects of perioperative medication on the nasal microbiome in patients with chronic sinusitis (CRS) 14/NTA/134 by investigating changes in the nasal and gut microbiome with additional commonly used antibiotics and steroids and how they relate to drug distribution. Study aim 1. The aim of this pilot study is to investigate the effects of routine peri-operative care medication (antibiotics and oral steroids), on: 1a. the gut microbiome and gastrointestinal side effects of patients with chronic sinusitis. 1b. changes in the nasal microbiome and inflammatory cytokines. 1c. elucidate any patterns in drug distribution at specific body sites (nose, gut) and any relationships between the pharmacokinetic profiles of the medication in these sites
Interventions
Patients presenting for the first time into the rhinology clinic with chronic sinusitis. Patients will receive one of four oral medications for 7 days along with other standard medical treatment. Doxycyline, roxythromycin, augmentin or prednisone
1) doxycycline 100mg tablet twice daily (DOXY group) (7 days)
2) augmentin 625mg three times daily (AUG group) (7 days)
3) roxithromycin 300mg once daily (ROX group) (7 days)
4) prednisone 30mg once daily (PRED group) (7 days)
To monitor adherence - pa
Patients presenting for the first time into the rhinology clinic with chronic sinusitis. Patients will receive one of four oral medications for 7 days along with other standard medical treatment. Doxycyline, roxythromycin, augmentin or prednisone 1) doxycycline 100mg tablet twice daily (DOXY group) (7 days) 2) augmentin 625mg three times daily (AUG group) (7 days) 3) roxithromycin 300mg once daily (ROX group) (7 days) 4) prednisone 30mg once daily (PRED group) (7 days) To monitor adherence - patients asked to keep a diary, will also look at drug tablet return
Sponsors
Dr Joey Siu
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria Patients diagnosed with CRS. Patients providing fully informed consent to participate in this study.
Exclusion criteria
Exclusion Criteria Patients who are acutely unwell. Patients with cystic fibrosis. Patients with a history of previous nasal surgery. Children (<16 years) Immunodeficiency (congenital or acquired) Congenital mucociliary problems (e.g. primary ciliary dyskinesia) Non-invasive and invasive fungal sinus disease Systemic vasculitis and granulomatous diseases Chronic gastrointestinal inflammatory or immune-mediated diseases History of cocaine abuse; Patients requiring sinus surgery for neoplasia Patients unable to consent (e.g. lack of mental capacity) Patients on oral antibiotics or systemic corticosteroids in the four weeks prior to recruitment Patients with known allergies to the 4 medications
Outcome results
None listed