The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation &

Status Completed

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.

Clinical Trial 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). ;

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

Clinical Trial Details

NCT number	NCT00985816
Study type	Interventional
Source	University of Bari
Contact
Status	Completed
Phase	Phase 0
Start date	October 2009
Completion date	October 2011

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms