Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/03/2007
Date assigned
28/03/2007
Last edited
01/11/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alan Smyth

ORCID ID

Contact details

Division of Respiratory Medicine
Clinical Sciences Building
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 823 1703
alan.smyth@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P2005V3

Study information

Scientific title

Acronym

The Garlic Against Pseudomonas (GAP) study

Study hypothesis

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

Approval received from the Nottingham Research Ethics Committee 1 on the 9th November 2005 (ref: 05/Q2403/135).

Study design

Double blind, randomised, placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Macerated garlic

Primary outcome measures

Levels of acyl-homoserine lactones and other quorum sensing molecules (such as quinolones) in sputum and plasma at baseline and eight weeks.

Secondary outcome measures

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

Overall trial start date

01/04/2007

Overall trial end date

31/03/2008

Reason abandoned

Eligibility

Participant 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. Patient’s consent or parental consent with child’s assent

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

30 patients: 15 less than 16 years, and 15 greater than 16 years

Participant 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

Recruitment start date

01/04/2007

Recruitment end date

31/03/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Respiratory Medicine
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

c/o Dr Paul Cartledge
Head of Research Grants and Contracts
University of Nottingham Research Innovation Services
A18 Trent Building
University Park
Nottingham
NG7 2RD
United Kingdom
+44 (0)115 951 5679
bbzpnc@gwmail.nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/ris/

Funders

Funder type

Industry

Funder name

EU Marie Curie Fellowship (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Boots (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Nottingham Institute of Clinical Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS Research & Development (Nottingham City Hospital) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20306535

Publication citations

  1. Results

    Smyth AR, Cifelli PM, Ortori CA, Righetti K, Lewis S, Erskine P, Holland ED, Givskov M, Williams P, Cámara M, Barrett DA, Knox A, Garlic as an inhibitor of Pseudomonas aeruginosa quorum sensing in cystic fibrosis--a pilot randomized controlled trial., Pediatr. Pulmonol., 2010, 45, 4, 356-362, doi: 10.1002/ppul.21193.

Additional files

Editorial Notes