Probiotics and Early Microbial Contact in Preterm Neonates (ProPre)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Turku University Hospital
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: April 29, 2014
Last verified: April 2014

October 10, 2011
April 29, 2014
April 2014
April 2016   (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
Same as current
Complete list of historical versions of study NCT01454661 on ClinicalTrials.gov Archive Site
  • Intestinal immunity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Intestinal immune gene expression profiles will be assessed from fecal samples.
  • Breast milk compostion [ Time Frame: 1 months ] [ Designated as safety issue: No ]
    Immunological and microbiological properties of breast milk will be investigated.
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: LGG+Bb-12
    A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.
  • Dietary Supplement: Placebo
    Microcrystalline cellulose is used as placebo.
  • 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: LGG+Bb-12 mother - Placebo infant
    A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo.
    Intervention: Dietary Supplement: LGG+Bb-12
  • Active Comparator: Pacebo mother - LGG+Bb-12 infant
    Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12
    Intervention: Dietary Supplement: LGG+Bb-12
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2016
April 2016   (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
April 2014

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