At a glance
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Prophylactic Probiotics to Extremely Low Birth Weight Prematures
In Brief
A Phase 2 clinical trial evaluating Lactobacillus reuteri and Placebo for Feeding; Difficult, Newborn and 3 related conditions. Completed, enrolled 134 participants across 2 sites.
Detailed Summary
Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition. The aim of the study is to evaluate whether supplementation with the probiotic bacterium Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight increases feeding tolerance to breast milk and thereby improves nutrition, increases growth and reduces serious complications and mortality in this population. Beyond this, possible mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.
Study Details
Timeline
Interventions
Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day
Oil drops without Lactobacillus reuteri