Pilot, comparative, randomized, controlled trial assessing the safety and efficacy of manuka honey in the treatment of sinonasal bacterial infections in chronic rhinosinusitis

Pilot, comparative, randomized controlled trial assessing the safety and efficacy of manuka honey augmented with methylglyoxal targeting bacterial infections and biofilms in patients with Chronic Rhinosinusitis in a clinical setting

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000136404

Enrollment

Registered

2016-02-05

Start date

2016-02-08

Completion date

2017-02-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this project is to develop a clinically safe and effective treatment against bacterial infections in patients with chronic rhinosinustis (CRS). Current standard antibiotic therapy often fails to treat sinonasal infections, and we therefore need to develop novel, effective therapeutics. Previous in vitro and in vivo work have found manuka honey augmented with additional active ingredient methylglyoxal (MGO) to be effective against a bacterial infections. We hypothesis that manuka honey with augmented MGO will effectively treat infections in the sinonasal region of patients with CRS.

Interventions

Patients in the treatment group will receive 28 pre-prepared sinonasal flush bottles containing 240mL of 16.5% manuka honey and 1.3mg/mL methylglyoxal. They will be asked to utilize the flushes twice daily for 14 days. They will also receive 20 encapsulated dextrose tablets and will be requested to take these orally twice a day for 10 days in parallel with the honey flushes. Patients are asked to return any unused bottles and/or tablets at the end of the study to monitor treatment adherence.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

(1) Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months (2) Have had at least one operation for their chronic rhinosinusitis (3) Continue to have ongoing symptoms despite surgical management (4) Have a positive sinonasal swab that indicates a bacterial infection (5) Over 18 years of age (6) Are able to give written informed consent (7) Are local patients who will be returning to this centre for postoperative follow-up care

Exclusion criteria

(1) A diagnosis of cystic fibrosis (2) Pregnant or breastfeeding (3) Immunocompromised patients (4) Patients actively taking oral steroids (5) Patients who have used antibiotics within 1 month prior to the trial. (6) Fructose intolerance/allergy

Outcome results