The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns
|Preterm Birth||Dietary Supplement: Lactobacillus Reuteri Dietary Supplement: Placebo||Early Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns|
- 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 [ Time Frame: 21 days ]
- Mechanisms of action of L.reuteri [ Time Frame: 21 days ]
|Study Start Date:||October 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: L reuteri DSM 17938
L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together with pharmaceutical grade silicon dioxide to give the product the correct rheological properties (Connolly, 2005). The placebo consists of an identical formulation except that the L. reuteri is not present. This dose of the oil formulation with L. reuteri has been shown to induce significant colonisation in infants and is well-tolerated (Abrahamsson et al., 2007; Savino et al., 2007; Indrio et al., 2008).
Dietary Supplement: Lactobacillus Reuteri
L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985816
|Principal Investigator:||Flavia Indrio||University of Bari|