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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985816
First Posted: September 28, 2009
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Bari
  Purpose
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.

Condition Intervention Phase
Preterm Birth Dietary Supplement: Lactobacillus Reuteri Dietary Supplement: Placebo Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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

Resource links provided by NLM:


Further study details as provided by University of Bari:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Mechanisms of action of L.reuteri [ Time Frame: 21 days ]

Estimated Enrollment: 80
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

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).
  Eligibility

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age 30 - 32 weeks. Gestational age will be defined by the best estimate based on prenatal ultrasound in the first trimester, DLM and/or Balard Score after birth.

Exclusion Criteria:

  • Cardiovascular or (respiratory) instability after 48 hours of age - Chromosomal anomalies.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985816


Locations
Italy
Flavia Indrio
Bari, Italy
Sponsors and Collaborators
University of Bari
Investigators
Principal Investigator: Flavia Indrio University of Bari
  More Information

Responsible Party: University of Bari Departement of Pediatrics, Flavia Indrio
ClinicalTrials.gov Identifier: NCT00985816     History of Changes
Other Study ID Numbers: FI-LR2009
First Submitted: September 25, 2009
First Posted: September 28, 2009
Last Update Posted: November 8, 2011
Last Verified: September 2009

Keywords provided by University of Bari:
Preterm
newborns
Gastric
Motility
Mucosal
immunity

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications