The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns
NCT ID: NCT00985816
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
80 participants
INTERVENTIONAL
2009-10-31
2011-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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).
Lactobacillus Reuteri
L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day
Placebo
Placebo
Placebo
Interventions
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Lactobacillus Reuteri
L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
* Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
* Parental refusal
* Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies that could alter the intestinal motility or the immune response of the premature infants.
3 Days
1 Month
ALL
No
Sponsors
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University of Bari
OTHER
Responsible Party
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Flavia Indrio
Principal Investigators
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Flavia Indrio
Role: PRINCIPAL_INVESTIGATOR
University of Bari
Locations
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Flavia Indrio
Bari, , Italy
Countries
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Other Identifiers
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FI-LR2009
Identifier Type: -
Identifier Source: org_study_id