Probiotics and Early Microbial Contact in Preterm Neonates (ProPre)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Turku University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
University of Turku
Massachusetts General Hospital
Information provided by (Responsible Party):
Samuli Rautava, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01454661
First received: October 10, 2011
Last updated: October 14, 2011
Last verified: October 2011

October 10, 2011
October 14, 2011
November 2011
December 2013   (final data collection date for primary outcome measure)
  • Gut microbiota [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life
  • Intestinal immunity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Investigation of neonatal intestinal immune gene expression from fecal samples during the first month of life.
  • Breast milk composition [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Measurement of microbiological and immunological properties of breast milk.
Same as current
Complete list of historical versions of study NCT01454661 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Probiotics and Early Microbial Contact in Preterm Neonates
Probiotic Modulation of Early Microbial Contact in Premature Infants

Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory intestinal disease. The investigators have previously demonstrated that administering probiotics to the lactating mother enhances the immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic intervention is yet to be established. The mechanisms by which probiotics exert their effects remain largely unknown.

This research project is based on the notion that modulation of early microbial contact by probiotics may provide a safe and effective means to improve the health of preterm infants. In particular, the investigators hypothesize that the protective potential of probiotics may be enhanced via breast milk by administering probiotics to the lactating mother. All of the potentially beneficial effects of probiotic bacteria are strain-specific and therefore preliminary laboratory and clinical research with regard to different physiological targets of probiotic intervention should be carried out to guide the design of large-scale clinical trials aiming show clinical efficacy and establish clinical practice. The purpose of this research project is to identify targets for probiotic therapy in premature neonates and to provide insight into the optimal probiotic strains and administration protocol the clinical efficacy of which will subsequently be tested in a randomized controlled trial.

The specific aims of the project are:

  1. To determine the effect of maternal consumption of probiotics during lactation on immunomodulatory properties of breast milk in mothers of premature infants. Concentrations of immunomodulatory factors and microbiological properties of breast milk will be measured.
  2. To investigate the impact of different probiotic administration protocols on gut microbiota composition in preterm infants. In particular, the issue whether maternal probiotic consumption instead or in addition to probiotics administered to the infant is effective will be elucidated. Different potential probiotic strains will be assessed.
  3. To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Premature; Infant, Light-for-dates
  • Breastfeeding
  • Dietary Supplement: LGG
    Lactobacillus rhamnosus GG 10E9 cfu / day
  • Dietary Supplement: La+Bb
    A combination of probiotic lactobacilli and bifidobacteria administered 10E9 cfu / day.
  • Dietary Supplement: Placebo
    Microcrystalline cellulose is used as placebo.
  • Active Comparator: LGG mother - LGG infant
    The probiotic LGG is administered both to the lactating mother and her infant.
    Intervention: Dietary Supplement: LGG
  • Active Comparator: placebo mother - LGG infant
    Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG.
    Intervention: Dietary Supplement: LGG
  • Placebo Comparator: placebo mother - placebo infant
    Placebo is administered to both the lactating mother and her infant.
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: LGG mother - placebo infant
    The probiotic LGG is administered to the lactating mother whilst the infant receives placebo.
    Intervention: Dietary Supplement: LGG
  • Active Comparator: LaBb mother - LaBb infant
    A combination of lactobacilli and bifidobacteria is administered both to the lactating mother and her infant.
    Intervention: Dietary Supplement: La+Bb
  • Active Comparator: LaBb mother - placebo infant
    A combination of lactobacilli and bifidobacteria is administered to the lactating mother whilst the infant receives placebo.
    Intervention: Dietary Supplement: La+Bb
  • Active Comparator: Pacebo mother - LaBb infant
    Placebo is administered to the lactating mother, the infant receives a combination of lactobacilli and bifidobacteria.
    Intervention: Dietary Supplement: La+Bb
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
140
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • premature infant born at <35 weeks gestational age

Exclusion Criteria:

  • severe asphyxia
  • significant anomalies
Both
up to 3 Days
Yes
Contact: Samuli Rautava, MD, PhD +358 40 7033166 samrau@utu.fi
Finland
 
NCT01454661
ETMK 104/180/2011
No
Samuli Rautava, Turku University Hospital
Turku University Hospital
  • University of Turku
  • Massachusetts General Hospital
Principal Investigator: Samuli Rautava, MD, PhD Turku University Hospital
Turku University Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP