A randomised controlled trial (pilot study) of the use of macerated garlic in patients with cystic fibrosis who have pulmonary infection with Pseudomonas aeruginosa

ISRCTN	ISRCTN21133397
DOI	https://doi.org/10.1186/ISRCTN21133397
Protocol serial number	P2005V3
Sponsor	University of Nottingham (UK)
Funders	EU Marie Curie Fellowship (UK), Boots (UK), University of Nottingham Institute of Clinical Research (UK), NHS Research & Development (Nottingham City Hospital) (UK)

Submission date: 08/03/2007
Registration date: 28/03/2007
Last edited: 01/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alan Smyth
Scientific

Division of Respiratory Medicine
Clinical Sciences Building
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 823 1703
Email	alan.smyth@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Double blind, randomised, placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The Garlic Against Pseudomonas (GAP) study
Study objectives	That garlic extract can inhibit quorum sensing molecules, produced by Pseudomonas aeruginosa, as measured in sputum and plasma from patients with cystic fibrosis.
Ethics approval(s)	Approval received from the Nottingham Research Ethics Committee 1 on the 9th November 2005 (ref: 05/Q2403/135).
Health condition(s) or problem(s) studied	Cystic fibrosis
Intervention	1. Placebo: one capsule once daily (656.01 mg of olive oil and 9.99 mg cardamom oil) for eight weeks. 2. Garlic: one capsule once daily (656.01 mg of garlic oil macerate and 9.99 mg cardamom oil) for eight weeks. All outcome data will be collected at the eight week visit and there will be no further follow up.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Macerated garlic
Primary outcome measure(s)	Levels of acyl-homoserine lactones and other quorum sensing molecules (such as quinolones) in sputum and plasma at baseline and eight weeks.
Key secondary outcome measure(s)	Microbiology investigations: 1. Quantitative sputum culture at baseline and eight weeks 2. Qualitative microbiology: a. mucoid/non-mucoid phenotype at baseline and eight weeks b. antibiotic resistance pattern - Minimum Inhibitory Concentrations (MICs) to ceftazidime and tobramycin at baseline and eight weeks c. garlic metabolites in sputum and plasma at baseline and eight weeks Clinical investigations: 1. Pulmonary function at baseline and eight weeks 2. Weight and height at baseline and eight weeks 3. Clinical score at baseline and eight weeks 4. Number of pulmonary exacerbations and requirement for oral and intravenous antibiotics whilst on study medication at baseline and eight weeks 5. Adverse effects and patient acceptability questionnaire at eight weeks only 6. Serum lipids, liver function, C-reactive protein, clotting and full blood count at baseline and eight weeks
Completion date	31/03/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	30
Key inclusion criteria	The following patients with cystic fibrosis will be eligible: 1. Chronic pulmonary infection with P. aeruginosa 2. Can produce sputum 3. Are able to swallow the capsules 4. Over eight years 5. Are not currently suffering from an acute pulmonary exacerbation, requiring oral or intravenous antibiotics 6. Patients consent or parental consent with childs assent
Key exclusion criteria	1. Prolonged clotting or platelet count below 150 x 10^9/L at baseline 2. Abnormal liver function 3. Pregnant or lactating mothers
Date of first enrolment	01/04/2007
Date of final enrolment	31/03/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Division of Respiratory Medicine

Nottingham
NG5 1PB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No