The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns - Full Text View

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	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Lactobacillus

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mechanisms of action of L.reuteri [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

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 Other Name: placebo

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

Other Name: 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

Ages Eligible for Study:	up to 1 Month
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985816

Locations

Italy
Flavia Indrio
Bari, Italy

Sponsors and Collaborators

University of Bari

Investigators

Principal Investigator:

Flavia Indrio

University of Bari

More Information

No publications provided

Responsible Party:	University of Bari Departement of Pediatrics, Flavia Indrio
ClinicalTrials.gov Identifier:	NCT00985816 History of Changes
Other Study ID Numbers:	FI-LR2009
Study First Received:	September 25, 2009
Last Updated:	November 7, 2011
Health Authority:	Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013