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
  Purpose

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.

Condition Intervention
Premature; Infant, Light-for-dates
Breastfeeding
Dietary Supplement: LGG
Dietary Supplement: LGG+Bb-12
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Probiotic Modulation of Early Microbial Contact in Premature Infants

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: placebo mother - LGG infant
Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG.
Dietary Supplement: LGG
Lactobacillus rhamnosus GG 10E9 cfu / day
Placebo Comparator: placebo mother - placebo infant
Placebo is administered to both the lactating mother and her infant.
Dietary Supplement: Placebo
Microcrystalline cellulose is used as placebo.
Active Comparator: LGG mother - placebo infant
The probiotic LGG is administered to the lactating mother whilst the infant receives placebo.
Dietary Supplement: LGG
Lactobacillus rhamnosus GG 10E9 cfu / day
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.
Dietary Supplement: LGG+Bb-12
A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.
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
Dietary Supplement: LGG+Bb-12
A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • premature infant born at <35 weeks gestational age

Exclusion Criteria:

  • severe asphyxia
  • significant anomalies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454661

Contacts
Contact: Samuli Rautava, MD, PhD +358 40 7033166 samrau@utu.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, 20520
Contact: Samuli Rautava, MD, PhD    +358 40 7033166    samrau@utu.fi   
Sponsors and Collaborators
Turku University Hospital
University of Turku
Massachusetts General Hospital
Investigators
Principal Investigator: Samuli Rautava, MD, PhD Turku University Hospital
  More Information

No publications provided

Responsible Party: Samuli Rautava, Principal Investigator, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01454661     History of Changes
Other Study ID Numbers: ETMK 104/180/2011
Study First Received: October 10, 2011
Last Updated: April 29, 2014
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Keywords provided by Turku University Hospital:
Probiotics
Premature infant
Intestinal microbiota
Intestinal immunity
Breastfeeding

ClinicalTrials.gov processed this record on August 20, 2014