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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000311-98-GB

Enrollment

Registered

2005-09-14

Start date

2005-11-09

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

Chronic pulmonary infection with Pseudomonas aeruginosa in patients with cystic fibrosis

Interventions

Product Name: Boots High Strength Garlic Odour Controlled Product Code: SE10599 Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsul

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Chronic pulmonary infection with P.aeruginosa ? Can produce sputum ? Are able to swallow the capsules ? Over 8 years ? Are not currently suffering from an acute pulmonary exacerbation, requiring oral or intravenous antibiotics ? Patient’s consent or parental consent with child’s assent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? Prolonged clotting or platelet count below 150 x 109/L at baseline ? Abnormal liver function ? Pregnant or lactating mothers

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Assay for acylhomoserine lactones (quorum sensing molecules) in sputum, using the methodology described in the attached protocol.; Main Objective: ? Proof of principle that garlic extract can inhibit quorum sensing molecules as measured in sputum in vivo ? To develop an assay for garlic components, including ajoene. ? Mean & standard deviation data from a representative sample of CF patients to enable the design of a larger trial. ; Secondary Objective: o evaluate the effect of 8 weeks of treatment with macerated garlic on: ? Quantitative sputum culture. ? Qualitative microbiology (mucoid / non-mucoid phenotype & antibiotic resistance pattern) ? Pulmonary function ? Weight and height ? Clinical score ? Number of pulmonary exacerbations and requirement for oral and intravenous antibiotics whilst on study medication ? Adverse effects and patient acceptability questionnaire ? Serum lipids, liver function, C reactive protein, clotting & full blood count	—

Measure

Time frame

Primary end point(s): Assay for acylhomoserine lactones (quorum sensing molecules) in sputum, using the methodology described in the attached protocol.; Main Objective: ? Proof of principle that garlic extract can inhibit quorum sensing molecules as measured in sputum in vivo ? To develop an assay for garlic components, including ajoene. ? Mean & standard deviation data from a representative sample of CF patients to enable the design of a larger trial. ; Secondary Objective: o evaluate the effect of 8 weeks of treatment with macerated garlic on: ? Quantitative sputum culture. ? Qualitative microbiology (mucoid / non-mucoid phenotype & antibiotic resistance pattern) ? Pulmonary function ? Weight and height ? Clinical score ? Number of pulmonary exacerbations and requirement for oral and intravenous antibiotics whilst on study medication ? Adverse effects and patient acceptability questionnaire ? Serum lipids, liver function, C reactive protein, clotting & full blood count

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Countries

United Kingdom

Outcome results

None listed

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