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

Disbiosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05936541
• Other study ID #: 04-10/05/2022
• Status: Completed
• Phase: N/A
• Start date: January 5, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: July 2023
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 25, 2021
• Est. primary completion date: May 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Disbiosis
• Dysbiosis

Intervention

Dietary Supplement:
• Probiotic Bifidobacterium Bifidum PRL2010
Probiotic supplement

Other:
• Control group
No probiotic supplementation

Locations

Country	Name	City	State
Italy	Neonatology and Neonatal Intensive Care Unit of Santa Maria Goretti Hospital	Latina

Sponsors (2)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences	Ospedale Santa Maria Goretti

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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