Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05936541 |
| Other study ID # |
04-10/05/2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
