search
Back to results

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

Primary Purpose

Disbiosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Probiotic Bifidobacterium Bifidum PRL2010
Control group
Sponsored by
Liaquat University of Medical & Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disbiosis

Eligibility Criteria

1 Month - 1 Year (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Neonatology and Neonatal Intensive Care Unit of Santa Maria Goretti Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Probiotic Bifidobacterium Bifidum PRL2010

Control

Arm Description

Participants in this group will receive probiotic Bifidobacterium Bifidum PRL2010 supplementation from the time of discharge to a daily for the 6 months

Participants in this group will not receive probiotic probiotic supplementation

Outcomes

Primary Outcome Measures

Number of participants with disease
Number of participants with skin, respiratory and gastrointestinal diseases assessed with a questionnaire submitted to parents

Secondary Outcome Measures

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

Full Information

First Posted
May 30, 2023
Last Updated
July 6, 2023
Sponsor
Liaquat University of Medical & Health Sciences
Collaborators
Ospedale Santa Maria Goretti
search

1. Study Identification

Unique Protocol Identification Number
NCT05936541
Brief Title
Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants
Official Title
Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
May 2, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat University of Medical & Health Sciences
Collaborators
Ospedale Santa Maria Goretti

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disbiosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Probiotic Bifidobacterium Bifidum PRL2010
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Bifidobacterium Bifidum PRL2010
Arm Type
Experimental
Arm Description
Participants in this group will receive probiotic Bifidobacterium Bifidum PRL2010 supplementation from the time of discharge to a daily for the 6 months
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants in this group will not receive probiotic probiotic supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Bifidobacterium Bifidum PRL2010
Intervention Description
Probiotic supplement
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No probiotic supplementation
Primary Outcome Measure Information:
Title
Number of participants with disease
Description
Number of participants with skin, respiratory and gastrointestinal diseases assessed with a questionnaire submitted to parents
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Variation in children gut microbiota composition
Description
Variation in gut microbiota composition of children born by caesarean section assessed by faecal colonic microbiota analysis with 16S rRNA technology
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Neonatology and Neonatal Intensive Care Unit of Santa Maria Goretti Hospital
City
Latina
ZIP/Postal Code
LT 04100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs