Manuka Honey Sinus Rinse Study

NCT04589897 | Completed DMC

• 1 other identifier: JMR1075-100
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

A trial investigating the effect of a sinus rinse in people with CF

Conditions

Cystic Fibrosis; Infection, Bacterial

Outcome Measures

Primary Outcomes (1)

• Change in Sino-Nasal Outcome Test 22 (SNOT- 22) Score

  Does the addition of manuka honey to the sinus rinse change the Sino Nasal Outcome Test (SNOT)-22 score of patients with cystic fibrosis? The SNOT-22 scale runs from 0 -110 and a higher score indicating worse symptoms

  Baseline and day 30 (+-7 days)

Secondary Outcomes (2)

• Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Score

  Baseline and day 30 (+-7 days)

• Bacterial type and number

  Baseline and day 30 (+-7 days)

Study Arms (2)

Experimental

EXPERIMENTAL

Manuka honey sinus rinse

Device: Manuka honey sinus rinse

Standard

ACTIVE COMPARATOR

Standard sinus rinse

Device: Standard sinus rinse

Interventions

Manuka honey sinus rinse DEVICE

Will follow a modified NHS nasal rinse protocol with the addition of manuka honey

Experimental

Standard sinus rinse DEVICE

will follow the standard NHS nasal rinse protocol

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is willing and able to give informed consent.
• The patient must be ≥ 18 years.
• The patient must have an established diagnosis of CF (one or more of the following) Sweat chloride \>60mEq/L Presence of two CF causing mutations.
• The patient must have chronic symptoms of rhinosinusitis according to the criteria of the European Position Paper on Rhinosinusitis (appendix A).
• The patient scores greater ≥ 7 on their SNOT-22 questionnaire.

You may not qualify if:

• The patient has ever tested positive for the bacteria Mycobacterium tuberculosis.
• The patient is currently using a nasal rinse protocol.
• The patient has undergone sinus surgery within 6 months.
• The patient suffers from nasal bleeding.
• The patient is currently undergoing systemic antibiotic therapy for infective exacerbation.
• The patient is using overnight oxygen via nasal cannula.
• The patient is participating in another clinical trial or has done so within the last 30 days.
• The patient has a known allergy to bee products.
• The patient has an objection to the use of bee products

Sponsors & Collaborators

• Swansea University: lead
• University Hospital of Wales: collaborator

Study Sites (1)

All Wales Adult Cystic Fibrosis Center, University Hospital Llandough

Cardiff, CF62 2XX, United Kingdom

Location

Related Publications (1)

• Roberts AEL, Xanthe C, Hopkins AL, Bodger O, Lewis P, Mahenthiralingam E, Duckers J, Jenkins RE. A pilot study investigating the effects of a manuka honey sinus rinse compared to a standard sinus rinse on sino-nasal outcome test scores in cystic fibrosis patients. Pilot Feasibility Stud. 2022 Sep 24;8(1):216. doi: 10.1186/s40814-022-01175-0.

  PMID: 36153609 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Bacterial Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bacterial Infections and Mycoses; Infections

Study Officials

• Jamie Duckers

  National Health Service, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 19, 2020
• Study Start: January 7, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: September 22, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Anyone who wishes to access the data.

Locations

GB (1)