Dettagli per singolo studio

DEC-NET Serial number GB300

Published online	10/08/2004 15.08.00
Last updated	02/08/2005 12.38.51


This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	02/2003 30
Major Disease (ICD9 class)	Cystic fibrosis
Experimental drug
Lactobacillus GG Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	0-16 years
Eligibility criteria
Inclusion criteria
Children with cystic fibrosis Attendance at the Royal London Hospital CF clinic Requires the use of antibiotics for chest exacerbation.
Exclusion criteria
Already on probiotic
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind Cross-over
Purpose of study
To evaluate if a probiotic given in conjunction with usual antibiotic course in children with cystic fibrosis reduces the antibiotic associated gastro-intestinal symptoms, ie. nausea, diarrhoea, abdominal pain. Seecondary outcome measures will also include weight, lung function and changes in microbiology of cough swabs/sputum cultures.
Primary outcomes
Stool frequency
Secondary outcomes
Stool bacterial load
Summary of study design, objectives, and ongoing research findings
Blinded Randomised controlled trial. Stool diary and sample when well at recruitment. Randomised to probiotic or placebo with chest exacerbation requiring oral or IV antibiotics. Stool diary and sample on day 3 of treatment. Re-diaried post treatment course. Cross-over to placebo or treatment with second respiratory exacerbation requiring antibiotics. Stool diary and sample 3 days into 2nd course.