Dettagli per singolo studio

DEC-NET Serial number GB353

Published online	22/02/2005 10.25.00
Last updated	06/03/2006 10.02.47


This trial has been approved by an ethics committee
Current trial status	Planned (i.e. not yet recruiting participants)
Target N. of subjects	30
Major Disease (ICD9 class)	CYSTIC FIBROSIS
Experimental drug
Garlic, Allium Satirum Treatment regimen (dosage and duration) Placebo - two capsules twice a day Low strength garlic - two garlic capsules once a day and two placebo capsules daily High strength garlic - two garlic capsules twice daily
Gender	Both
Age (range)	2-16 and >16
Eligibility criteria
Inclusion criteria
Chronic pulmonary infection with Psedomonas aeruginosa Can produce sputum Are able to swallow capsules Are not currently suffering from an acute pulmonary exacerbation, requiring oral or intravenous antibiotics Patient's consent or parental consent with child's assent
Exclusion criteria
Prolonged clotting or platelet count below 150x10^9/L at baseline
Trial design/methodology
Phase	2
Kind of study	Bioequivalence
Design	Controlled Randomised Blinded Double blind
Purpose of study
To provide preliminary data on the use of High Strength Garlic Capsules in patients with cystic fibrosis who have chronic pulmonary infection with Pseudomonas aeruginosa
Primary outcomes
Proof of principle that garlic extract can inhibit quorum sensing molecules as measured in sputum in vivo
Secondary outcomes
Mean and standard deviation data from a representative sample of cystic fibrosis patients to enable the design of a larger trial
Summary of study design, objectives, and ongoing research findings
Double blind, parallel group, placebo controlled and masked, dose finding, randomised controlled trial (pilot study) in patients with cystic fibrosis who have chronic pulmonary infection with Pseudomonas aeruginosa. To evaluate whether the proposed garlic dosage leads to measurable levels of serum and spitum from study patients. These specimens will be analysed spectroscopically for garlic metabolites and by bioassay, for inhibition of quorum sensing. The levels of the cytokines iL-8, G-CSF and GM-CSF will be examined at baseline and at the end of treatment. The active and placebo groups will be compared.