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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985816
• Other study ID #: FI-LR2009
• Status: Completed
• Phase: Phase 0
• First received: September 25, 2009
• Last updated: November 7, 2011
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2009
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Dietary Supplement:
• Lactobacillus Reuteri
L. reuteri DSM 17938 will be given at a dose of 1x108 colony forming units (CFU)/day
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	Flavia Indrio	Bari

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		21 days	Yes
Secondary	Mechanisms of action of L.reuteri		21 days	Yes