Probiotics and Early Microbial Contact in Preterm Neonates

NCT01454661 | Unknown

• 1 other identifier: ETMK 104/180/2011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 3.To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.

Conditions

Premature; Infant, Light-for-dates; Breastfeeding

Keywords

Probiotics; Premature infant; Intestinal microbiota; Intestinal immunity; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Gut microbiota

  Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life

  1 month

Secondary Outcomes (2)

• Intestinal immunity

  1 month

• Breast milk compostion

  1 months

Study Arms (5)

placebo mother - LGG infant

ACTIVE COMPARATOR

Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG.

Dietary Supplement: LGG

placebo mother - placebo infant

PLACEBO COMPARATOR

Placebo is administered to both the lactating mother and her infant.

Dietary Supplement: Placebo

LGG mother - placebo infant

ACTIVE COMPARATOR

The probiotic LGG is administered to the lactating mother whilst the infant receives placebo.

Dietary Supplement: LGG

LGG+Bb-12 mother - Placebo infant

ACTIVE COMPARATOR

A combination of the probiotics LGG and Bb-12 is administered to the lactating mother, the infant receives placebo.

Dietary Supplement: LGG+Bb-12

Pacebo mother - LGG+Bb-12 infant

ACTIVE COMPARATOR

Placebo is administered to the lactating mother, the infant receives a combination of the probiotics LGG and Bb-12

Dietary Supplement: LGG+Bb-12

Interventions

LGG DIETARY_SUPPLEMENT

Lactobacillus rhamnosus GG 10E9 cfu / day

LGG mother - placebo infant; placebo mother - LGG infant

LGG+Bb-12 DIETARY_SUPPLEMENT

A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.

LGG+Bb-12 mother - Placebo infant; Pacebo mother - LGG+Bb-12 infant

Placebo DIETARY_SUPPLEMENT

Microcrystalline cellulose is used as placebo.

placebo mother - placebo infant

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• premature infant born at \<35 weeks gestational age

You may not qualify if:

• severe asphyxia
• significant anomalies

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

RECRUITING

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Samuli Rautava, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuli Rautava, MD, PhD

CONTACT

+358 40 7033166; samrau@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 19, 2011
• Study Start: April 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

FI (1)