Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants

Study Overview
=================
Brief Summary
-----------------
This study is aimed to manipulate the composition of the intestinal flora of the infants born by caesarian section through the administration of the probiotic strain Bifidobacterium bifidum PRL 2010, in order to evaluate its effects on gut dysbiosis during the first 6 month of life.

Detailed Description
-----------------
There has been increasing interest in the field of human microbiome, considering its impact on health and diseases. The gastrointestinal tract represents the most heavily inhabited organ with microorganisms, counting 10 times the total number of human cells; for this reason, the gut microbiome has recently been referred as a proper organ. Intestinal microbial composition is unique for each individual and it is influenced by numerous factors, of which delivery mode is an important one with gestational age of the newborn, type of feeding and intrapartum or neonatal antibiotic therapy. Recent reports suggest that dysbiosis secondary to delivery mode affects the subsequent regulation of immune response and may be associated with several pathologic conditions, for example allergic diseases or obesity. Moreover, gut microbiome seems to impact on neurodevelopment during first six months of life. Bifidobacteria is the most represented group of intestinal microbiota in the newborn, followed by Enterobacteria, and it plays an important role in the infant gut. This includes the fundamental function performed by Bifidobacterium bifidum: it supplies the nutritional material to the rest of the microbial community, particularly Bifidobacterium breve and Bifidobacterium longum infantis that are the other typical bifidobacteria of the newborn. It is a powerful metabolizer of the intestinal mucus and the HMOs (Human Milk Oligosaccharides) present in breast milk. Thanks to its exocitable enzymes, the degradative catabolism occurs in the intestinal environment. Thus, B. bifidum favour the increase in intestinal richness and biodiversity (9), which correlates with the host's state of health. However, bifidobacteria is reduced in infants born by cesarean delivery. Aim of the study is to assess if the Bifidobacterium Bifidum PRL2010 supplementation effectively ameliorat bifidocentric dysbiosis due to the delivery mode and we want to confirm this by analyzing fecal microbiota in caesarean birth infants.

Official Title
-----------------
Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants

Conditions
-----------------
Disbiosis

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic Bifidobacterium Bifidum PRL2010
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants born by caesarian delivery Parents informed written consent Exclusion Criteria Suspension of the administration of the probiotic strain for a period of time exceeding 7 days Interruption of the administration of the probiotic strain before the completion of the sixth month Replacement of Bifidobacterium bifidum PRL2010 with another strain Refusal to collect the fecal sample expressed by parents Major congenital birth deformities Acute illness at enrollment Any condition affecting food intake or metabolism Maternal mental and psychosomatic diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Probiotic Bifidobacterium Bifidum PRL2010
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Bifidobacterium Bifidum PRL2010<br>Participants in this group will receive probiotic Bifidobacterium Bifidum PRL2010 supplementation from the time of discharge to a daily for the 6 months | Dietary Supplement: Probiotic Bifidobacterium Bifidum PRL2010<br>* Probiotic supplement<br>|
| Active Comparator: Control<br>Participants in this group will not receive probiotic probiotic supplementation | Other: Control group<br>* No probiotic supplementation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with disease | Number of participants with skin, respiratory and gastrointestinal diseases assessed with a questionnaire submitted to parents | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in children gut microbiota composition | Variation in gut microbiota composition of children born by caesarean section assessed by faecal colonic microbiota analysis with 16S rRNA technology | up to 6 months |