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

L

Liaquat University of Medical & Health Sciences

Status

Completed

Conditions

Disbiosis

Treatments

Other: Control group
Dietary Supplement: Probiotic Bifidobacterium Bifidum PRL2010

Study type

Interventional

Funder types

Other

Identifiers

NCT05936541
04-10/05/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

1 month to 1 year old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Probiotic Bifidobacterium Bifidum PRL2010
Experimental group
Description:
Participants in this group will receive probiotic Bifidobacterium Bifidum PRL2010 supplementation from the time of discharge to a daily for the 6 months
Treatment:
Dietary Supplement: Probiotic Bifidobacterium Bifidum PRL2010
Control
Active Comparator group
Description:
Participants in this group will not receive probiotic probiotic supplementation
Treatment:
Other: Control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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