The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content
Condition: Infantile Colic; Microbial Colonization; Crying
MeSH terms: Communicable Diseases; Infections; Colic
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Activia Probiotics Shot; Routine care
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The product contains Actiregularis - at least 2x106 cfu / g.; Routine care of the hospital will be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One blind, Randomized controlled Trials
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: infantile colic, colic, probiotics, maternal diet, microbiota