Status: Funded - Open
Probiotics in infants with cystic fibrosis: Effects of early intervention
(Keith) Chee Ooi, MBBS, Dip Paeds, PhD, FRACP
BACKGROUND: The gut is affected by intestinal dysbiosis (alterations in the microbiota) and inflammation, with animal and human studies in cystic fibrosis (CF) suggesting a strong link between imbalances between good vs. bad gut bacteria and the development of inflammation. Intestinal inflammation is associated with poor growth in children with CF, and probiotic studies in CF have demonstrated reduction in intestinal inflammation and improved weight, pulmonary outcomes and quality of life.
GAP: The natural history of the intestinal microbiota and inflammation in CF in the first year of life, and how this is altered with probiotics when commenced in early infancy and given daily during the first year of life will be evaluated through serial stool sampling.
HYPOTHESIS: The hypothesis is probiotics restores the abnormal gut microbiota in children with CF, which in turn reduces the risk of developing intestinal inflammation.
METHODS: This is a randomized controlled trial with longitudinal stool sample and data collection at 4 time points beginning from 1 to 12 months old. Comparisons in primary and secondary outcomes measures of gut microbiota and inflammation respectively will be performed on the following three cohorts: (i) CF subjects randomized to probiotics, (ii) CF subjects randomized to no probiotics, and (iii) healthy non-CF controls (without probiotics).
IMPACT: The role of the gut, and its disturbed microbiota, has largely been ignored in CF and intestinal inflammation, unlike airway inflammation, is currently not a therapeutic target in CF. Treatment of gut dysbiosis and inflammation may improve growth and nutritional outcomes, which reduces morbidity and mortality in CF.
University of New South Wales
New South Wales, Victoria