The Effects of Lactobacillus Reuteri DSM 17938 on Immunomodulation and Gastric Motility in Preterm Newborns
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.
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. To investigate possible mechanisms of action of Lactobacillus reuteri -Evaluate the impact in the host immune response by determining fecal cytokines, sIgA and calprotectin before and after 21 days of administration of L. reuteri. -Asses the rate of colonization with Lactobacillus reuteri after its exogenous administration.
2. To evaluate efficacy and safety of the administration of Lactobacillus reuteri to premature infants -Identify clinical beneficial effects secondary to the administration of Lactobacillus reuteri to this population of 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
- Identify any possible side effects and adverse events secondary to the administration of Lactobacillus reuteri to this population of 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).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Lactobacillus Reuteri, Placebo
Not yet recruiting
University of Bari
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00985816
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A species of gram-positive, rod-shaped LACTIC ACID bacteria found naturally in the human intestinal flora and BREAST MILK.
Cervical Length Measurement
A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.
Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete.
Postnatal deaths from BIRTH to 365 days after birth in a given population. Postneonatal mortality represents deaths between 28 days and 365 days after birth (as defined by National Center for Health Statistics). Neonatal mortality represents deaths from birth to 27 days after birth.
Official certifications by a physician recording the individual's birth date, place of birth, parentage and other required identifying data which are filed with the local registrar of vital statistics.
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