Probiotics and Early Microbial Contact in Preterm Neonates (ProPre)
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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:
- 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.
- 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.
- 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: La+Bb 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 |
- 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.
| Estimated Enrollment: | 140 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: LGG mother - LGG infant
The probiotic LGG is administered both to the lactating mother and her infant.
|
Dietary Supplement: LGG
Lactobacillus rhamnosus GG 10E9 cfu / day
|
|
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: LaBb mother - LaBb infant
A combination of lactobacilli and bifidobacteria is administered both to the lactating mother and her infant.
|
Dietary Supplement: La+Bb
A combination of probiotic lactobacilli and bifidobacteria administered 10E9 cfu / day.
|
|
Active Comparator: LaBb mother - placebo infant
A combination of lactobacilli and bifidobacteria is administered to the lactating mother whilst the infant receives placebo.
|
Dietary Supplement: La+Bb
A combination of probiotic lactobacilli and bifidobacteria administered 10E9 cfu / day.
|
|
Active Comparator: Pacebo mother - LaBb infant
Placebo is administered to the lactating mother, the infant receives a combination of lactobacilli and bifidobacteria.
|
Dietary Supplement: La+Bb
A combination of probiotic lactobacilli and bifidobacteria administered 10E9 cfu / day.
|
Eligibility| Ages Eligible for Study: | up to 3 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- premature infant born at <35 weeks gestational age
Exclusion Criteria:
- severe asphyxia
- significant anomalies
Contacts and Locations| Contact: Samuli Rautava, MD, PhD | +358 40 7033166 | samrau@utu.fi |
| Finland | |
| Turku University Hospital | Not yet recruiting |
| Turku, Finland, 20520 | |
| Contact: Samuli Rautava, MD, PhD +358 40 7033166 samrau@utu.fi | |
| 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: | October 14, 2011 |
| 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 May 22, 2013