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 |
| Secondary identifying numbers | P2005V3 |
- 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
Not provided at time of registration
Contact information
Dr Alan Smyth
Scientific
Scientific
Division of Respiratory Medicine
Clinical Sciences Building
Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
| Phone | +44 (0)115 823 1703 |
|---|---|
| alan.smyth@nottingham.ac.uk |
Study information
| Study design | Double blind, randomised, placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Approval received from the Nottingham Research Ethics Committee 1 on the 9th November 2005 (ref: 05/Q2403/135). |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Macerated garlic |
| Primary outcome measure | 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 study start date | 01/04/2007 |
| Overall study end date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 30 patients: 15 less than 16 years, and 15 greater than 16 years |
| 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. Patients consent or parental consent with childs assent |
| 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
- England
- United Kingdom
Study participating centre
Division of Respiratory Medicine
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
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
England
United Kingdom
| Phone | +44 (0)115 951 5679 |
|---|---|
| bbzpnc@gwmail.nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ris/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Industry
EU Marie Curie Fellowship (UK)
No information available
Boots (UK)
No information available
University of Nottingham Institute of Clinical Research (UK)
No information available
NHS Research & Development (Nottingham City Hospital) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
