Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Turku | OTHER |
| Massachusetts General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo mother - LGG infant | Active Comparator | Placebo is administered to the lactating mother whilst the infant receives the probiotic LGG. |
|
| placebo mother - placebo infant | Placebo Comparator | Placebo is administered to both the lactating mother and her infant. |
|
| LGG mother - placebo infant | Active Comparator | The probiotic LGG is administered to the lactating mother whilst the infant receives placebo. |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LGG | Dietary Supplement | Lactobacillus rhamnosus GG 10E9 cfu / day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota | Assessment of indigenous intestinal microbiota composition in premature neonates during the first month of life | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal immunity | Intestinal immune gene expression profiles will be assessed from fecal samples. | 1 month |
| Breast milk compostion | Immunological and microbiological properties of breast milk will be investigated. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuli Rautava, MD, PhD | Contact | +358 40 7033166 | samrau@utu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Samuli Rautava, MD, PhD | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Recruiting | Turku | 20520 | Finland |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LGG+Bb-12 | Dietary Supplement | A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each. |
|
| Placebo | Dietary Supplement | Microcrystalline cellulose is used as placebo. |
|
| 1 months |
| D000091642 | Urogenital Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |