NCT00985816

The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 3 Days – 1 Month
• Healthy volunteers: Not accepted

Summary

The investigators propose a Phase II interventional trial to investigate the role of Lactobacillus reuteri DSM 17938 on the intestinal motility and immune response of premature infants and further evaluate safety of the use of this probiotic in a population of premature infants.

Detailed description

Hypothesis Administration of Lactobacillus reuteri to premature infants will improve their intestinal motility when compared with infants receiving placebo. Primary Objective Evaluate the effects of L. reuteri in the intestinal motility by measuring the gastric emptying rate in infants before and after 21 consecutive days of administration of L. reuteri. Secondary Objectives 1. Mechanisms of action of L. reuteri - L.reuteri impact in the host immune response by determining fecal cytokines, sIgA and calprotectin before and after 21 days of administration - L.reuteri rate of colonization after its administration. 2\. Efficacy and safety of L. reuteri to premature infants - Clinical beneficial effects secondary to the administration of L. reuteri to premature infants. The following clinical outcomes will be identified and compared between groups: * Number of gastrointestinal symptoms (regurgitation, vomiting, stasis) * Days to full feeds. Number of days to reach full feeds defined as \> 120cc/kg/day) x2 days or more. * Days on parenteral nutrition * Weight gain defined as the number of days needed to reach 150% of birth weight * Length of hospital stay * Any possible side effects and adverse events secondary to the administration of L. reuteri to premature infants. * Incidence of late onset sepsis. * Incidence and severity of necrotizing enterocolitis categorized by Bell's classification * Use of antibiotics (number of days on antibiotics during the hospital stay) * Mortality (at 28 days after birth and at hospital discharge).

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus Reuteri	L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-09-28
• Last updated: 2011-11-08

Locations

1 site across 1 country: Italy