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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21133397

Enrollment

Registered

2007-03-28

Start date

2007-04-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Cystic fibrosis Nutritional, Metabolic, Endocrine Metabolic disorders

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026