Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04374955 |
| Other study ID # |
a6pu2f37 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 7, 2020 |
| Est. completion date |
June 1, 2021 |
Study information
| Verified date |
June 2021 |
| Source |
Halic University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to investigate the effect of probiotic added to the diet of mothers on
infantile colic in the postpartum period and the content of the neonatal intestinal
microbiota.
Description:
Infantile colic, by definition, is defined as excessive crying in the afternoon or evening,
with no specific reason, starting at the first weeks of newborn life, lasting at least 3
weeks, longer than 3 hours a day and more than 3 days a week. Infantile colic is a common
newborn problem worldwide, affecting approximately 20% of infants. Although infantile colic
is considered a self-limiting and benign problem, it is a stressful problem for both newborns
and parents.
It is thought that the factors affecting infantile colic etiology may be the mode of
delivery, diet, birth weight, intestinal contractions, lactose intolerance, food
hypersensitivity, gas, parental misinterpretation of the normal crying model, or various
combinations of the above. In recent years and related evidence, it has been suggested that
motility disorder and intestinal neuronal hyperexcitability are the most important pathogenic
factor in infantile colic etiology. However, increasing evidence suggests that changes in the
gut microbiota may contribute to the development of this condition. By definition, microbiota
is expressed as a collection of microorganisms within a certain environment or ecosystem.
While the microbiota formation forms pathogenic, commensal and symbiotic microorganisms found
in the human body, the formation of the intestinal microbiota (colonization with bacteria)
begins in the womb, with the transition from the vagina at birth, this colonization continues
intensely and the foundations of the intestinal microbiota are laid in the first 3 months of
life. The ideal situation for the microbiota is that the beneficial and harmful bacteria in
the intestinal flora stay in balance and form a healthy flora. While discussing what is a
healthy microbiota, it is expressed as dysbiosis in case of beneficial and harmful flora in
balance.
In infantile colic, when the microbial structure was evaluated, it was seen to be
characterized by different microbial patterns. In the first 2 weeks of life, infants with
infantile colic have been reported to have a lower variety and stability of the gut
microbiota. When we look at the studies about microbiota, it was seen that especially in
colic babies, E. coli bacteria is found to be excessive, and the amount of bifidobacterium
and lactobacilli are decreased. In this case, coliforms are reported to cause pain by
creating excessive gas and inflammatory lipopolysaccharides as a result of intestinal
fermentation. In addition, studies show that babies with colic differ from those without
babies without microbiota, whereas babies with colic showed low microbiota diversity and
stability in the first weeks of life, and no difference was observed in the 3 to 4 month
evaluations. Another important factor that plays a role in infantile colic etiology is diet.
Breast milk, which is the most important food source for the newborn, has a unique and
complex microbiological composition, rich oligosaccharide content, immunological factors and
a probiotic (in the form of Bifidobacterium and Lactobacillus) and prebiotics that have the
ability to ensure the content and mucosal development of the intestinal microbiota if taken
in sufficient quantity. human milk oligosaccharide (HMO)) combination. When the microbial
changes of the babies who were breastfed and fed formula formula were compared, it was
observed that the rate of bifidobacterium and microorganism content of the babies who were
breastfed were 10 times richer than the formula formula. In a study by Grönlund et al., 35-36
of pregnancy among 67 mothers. When the stool samples and breast milk samples taken from the
baby during the first week and in the 1st month were evaluated, it was found that the content
of bifidobacterium (the most dense bifidobacterium longum) in the stool content and milk of
the mother was the most important factor affecting the type and amount of bifidobacterium in
the baby's stool. These changes suggest that a condition of intestinal dysbiosis may play a
role in the expression of infantile colic symptoms by modulating various neural, endocrine,
immune, and humoral signaling pathways.
Scientists are trying to develop formulas by studying the relationships between colic and
microbiome. Accordingly, if changes in the intestinal microbiota really play a role in
infantile colic pathogenesis, it is thought that manipulation of the intestinal microbiome
may be a preventive measure and play a therapeutic role in the evolution of these diseases.
Considering that dysbiosis may play a role in infantile colic pathogenesis, there is interest
in modulating the gut microbiota, including the use of probiotics for the management of
infantile colic. In particular, it is a well-known probiotic that positively modifies the
composition of the intestinal microbiota of the Bifidobacterium species and the function of
the immune system.
Today, the effect of probiotics added to the diet of the mother and newborn nutrition on the
prevention of colic and microbiota content has been evaluated. One study found that when
probiotics were added to breast milk, it was effective in reducing the crying time in babies
with colic. In studies on the role of probiotics on colic, Lactobacillus species have also
been investigated for colic and microbiota, and have been found to reduce crying time in
studies showing that they are effective in colic management. When the effects of probiotics
given to infants with infantile colic on microbiota are examined, it has been observed in
studies that the harmful bacteria types such as H.pylori, Klebsiella, E.coli decrease the
amount of beneficial bacteria such as bifidobacterium and lactobacilli. However, studies
generally include the addition of probiotics to the diet of babies with colic, and a lack of
studies proving that the probiotics given to the mother or foods from natural probiotics
(fermented products such as beer, bread, wine, kefir, kumis and cheese) in the mother's diet
had a positive effect on the reduction of infantile colic.
This study was planned as a double-blind, randomized placebo-controlled trials in order to
evaluate the effect of the probiotic added to the diet of the mothers on infantile colic and
the contents of the neonatal intestinal microbiota in the postpartum period.
