Children's colic

Probiotics for infantile colic

Shokoufeh Ahmadipour a, b, Arash Fallahi c, Parisa Rahmani c, *

a Department of Pediatrics, Faculty of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran b Hepatitis Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran

c Pediatric Gastroenterology and Hepatology Research Center, Tehran University of Medical Sciences, Tehran, Iran

Pediatrics Center. These children were assigned randomly (using 2 blindedPedilact randomized trial) into two equal groups named PRR (Probiotic PRR receiving) and PCR (Placebo receiving) groups. The demographic

PCR information of the infants such as age and sex, maternal age, patient admission time and confounding factors such as passive smoker, family history of atopy, antibiotic use, and delivery type was recorded in both groups based on the statements provided by the mothers. The weight of the infants was also recorded.

Results: There was no significant difference in the distribution of infant's sex, mother's age, type of labor, type of nutrition, quality of life and exposure to smoke between the two groups. The weight of the newborns increased in each of the two groups and there was a significant increase in the PRR group (p value < 0.0001), while in the PCR group no significant growth was observed (p value ¼ 0.437). The frequency of crying in both groups decreased over the time, which was significant in PRR group only (p value < 0.001). There were no significant difference between PRR and PCR groups in fecal consistency and pattern of sleep on each day of 0, 7, 14, 21, and 28 (28 days p value ¼ 0.475 and 0.086, respectively).

1. Introduction

Infantile colic is one of the most common diseases that occurs in 10e30 percent of the infants in the world [1]. It occurs in healthy infants and is characterized by crying, often associated with facial flushing, lifting the legs, and flatulence. Clinically, infant colic is defined on the basis of the Wessel scale, which includes crying or tweezing for 3 h or more per day for at least 3 days a week for at least three weeks. Crying often reported in the afternoon. The symptoms appear at about 3 weeks and peak at the 8th-week, while the improvement is seen in after 12th week [1,2].

Infantile colic causes reduction in the parental mental health and leads to behavior problems in children [3]. Infants who cry more than 3 months are at risk of adverse outcomes during school years, including anxiety, aggressive behaviors and hyperactivity, allergies, sleep disorders [4], and are likely to encounter mental health problem in the coming years [5].

Considering the importance of colic, in the recent years, a number of therapeutic approaches are under consideration. The use of probiotics can be therapeutically effective for colic, as probiotics have been shown to be effective for the treatment of diseases, including colic, inducing changes in the microbial flora of the intestines and changes in intestinal pH [6].

A number of studies have been conducted to evaluate the effects of probiotics in colic treatment [7e9]. The benefits of prolonged use of probiotics and prebiotics have been proven to increase immunity, as well as some specific probiotics preventing many gastro-intestinal (GI) problems such as necrotizing enterocolitis, H. pylori gastritis and infantile colic [10,11]. Although probiotics play a significant role in the treatment of gastrointestinal diseases in children [12,13], the use of probiotic in colic therapy still requires further investigation [14].

Considering the prevalence and importance of infant colic and its impact on the lives of the infants and their families, this study is designed to evaluate the therapeutic role of pedilact probiotic drops for the treatment of infant's colic in children referred to the medical center in Tehran.

2. Methods

According to the Wessel criteria, infants below the age of 3 months suffering from colic were included in this study. This study was carried out on 72 infants who were referred to the Tehran children's medical Center because of colic. Of these infants, those who were 21e90 days old, full term, birth weight over 2500 g, breast feeding, gaining a weight of 100 g per week, crying for more than 3 h at least 3 days a week were entered into the study.

Exclusion criteria include infants having acute or chronic illness or digestive disorder confirmed by a pediatrician, participating in other clinical trials, neonates susceptibility to allergies from the ingredients of the product or placebo, chronic pulmonary disease, fever, diarrhea, underlying problem or specific disease or developmental disorder, digestive and nutritional problems including cow's milk protein intolerance, antibiotic and probiotic intake history and those taking nutrition by formula, and consumption of probiotics by the mother.

These children were assigned randomly (using double blinded randomizing) into two equal groups named PRR (Probiotic receiving) and PCR (Placebo receiving) groups. In the first group, which contains 48 infants, 5 drops of pedilact (manufacture by Zist-Thakhmir company, Iran) was administered once a day, which was a probiotic-prebiotic supplement containing of 109 colony count of Lactobacillus rhamnosus, Lactobacillus reuteri, Bifidobacterium infantis probiotics and Fructo-oligosaccharide (FOS) as a prebiotic. The second group received 5 drops of placebo once a day, which is produced by the same company.

The frequency and duration of crying, as well as fecal consistency and sleep pattern were assessed on days 7, 14, 21 and 28. The demographic information questionnaire, including infant's age and sex, maternal age, patient admission time and confounding factors such as passive smoker, family history of atopy, antibiotic use, and delivery type was recorded in both groups based on the statements of the infant's mother. The weight of the infants without diapers using digital scales were measured. This study was approved by the Research Ethics Board of Tehran University of Medical Sciences. IRCT CODE: IRCT20151129025287N3.

The datasets used and/or analyzed during the current study is obtainable from the corresponding author on reasonable request. Written informed consent was obtained from all participants parents.

2.1. Statistical analysis

Data were analyzed by SPSS software version 16.0 software. The qualitative variables were analyzed by Chi-square test, Spearman correlation test and quantitative variables by t-test. The statistical significance level was considered to be less than 0.05.

3. Results

In this study, a total of 72 infants were enrolled that included 48 infants in PRR group (25male/ 23female) and 24 infants in PCR group (10male/14female). The mean age of the PRR and PCR was 52.20 ± 41.885 and 49.36 ± 23.321 days respectively, which was not statistically significant (P value ¼ 0.769). Independent t-test test showed no significant difference between the gender distribution (P value ¼ 0.412), mother's age (P value ¼ 0.345), type of labor (P value ¼ 0.906), type of nutrition (P value ¼ 0.952), quality of life (P value ¼ 0.067) and exposure to smoke (P value ¼ 0.311) between the two groups. Additionally, the difference in mean weight of birth was not statistically significant before the administration of probiotic and placebo (P ¼ 0.235). (Table 1).

The weight of the newborns at the start of the study and on day 28 of the study was measured in both groups. Although the weight of the newborns increased in each of the two groups, there was a significant increase in the PRR group (P value < 0.0001), while it was not significant in the PCR group (P value ¼ 0.437).

According to the results of Repeated Measures ANOVA, we compared the frequency of crying in both groups. The decrease in the PRR group was significant (P value < 0.0001), while in the PCR group this decrease was not significant (P value ¼ 0.058

The duration of crying in newborns also decreased in both groups after 4 weeks. In this case, the duration of crying was significant in the PRR group (P value ¼ 0.025), while in the PCR group there was no significant difference (P value ¼ 0.169) (Fig. 1).

Fecal consistency was compared on 0, 7, 14, 21, and 28 days. Although there was no significant difference on any of these days, however, overall stool consistency in both groups was improved with time (Table 3). P value at day 28 was reported to be 0.475. Furthermore, there was no significant difference in the improvement of the sleeping pattern of infants following the treatment in both the group. P value ¼ 0.086 at day 28.

4. Discussion

Colic is one of the most common neonatal problems, however, the cause of colic is still not well defined [1,15]. The aim of this study is to assess the effect of pedilact probiotic drops for the treatment of infantile colic. The benefits of prolonged use of probiotics and prebiotics have been proven to boost the immune system, as well as some specific probiotics prevent necrotizing enterocolitis, and some may also be useful in H. pylori gastritis and infantile colic [11]. A recent study has shown that a specific strain of Lactobacillus reuteri can inhibit the growth of the gut-shaped gaseous form in the intestinal tract of chicken infants [16]. Probiotics and prebiotics can also alter GI movements in infants by stimulating gastric emptying [17].

A study by Vanenplas et al., reported the effects of probiotics and prebiotics on children's health. They showed that some probiotics can be useful in infantile colic and gelatin-associated H. pylori [11]. In a study by Calatayud et al., regarding the use of probiotics in children, it was reported that probiotics are useful in the prevention and treatment of many digestive diseases [10]. These results were confirmed by Wang et al. [18] and Kunze et al. [19] as well. The results of our study are also consistent with these studies and showed that the use of probiotic supplements can reduce the frequency (P value < 0.0001) and duration (P value ¼ 0.025) of crying in infants within 28 days of the therapy.

Previously, several studies were done similar to our study. In a study by Savino et al., 83 colic infants were randomly divided into a group of probiotics (Lactobacillus reuteri received 108 bacteria per day) and simethicone (60 mg/kg) daily for 28 days. On the seventh day, the crying period in the probiotic group was 159 h per day and the simethicone group was 177 h per day. On the 28th day, the probiotic group was 51 and the simethicone group was 145 h a day. No adverse side effects were reported [20]. In another study by Anabress et al., infants less than 5 months old were randomly divided into two groups. A probiotic group received 17938 Lactobacillus reuteri DSM and the other group received placebo, administered orally for 21 days once a day. The rate of responders to treatment in the probiotic group on days 14, 21, 28 and 87 was significantly higher than the control group. In addition, the mean crying rate was significantly lower in the probiotic group compared to control. There was also a clear reduction in parental feelings for colic severity and improved quality of family life in the probiotic group compared to controls. No adverse effects were reported in the study [7]. In Szajewska et al. [8] and Savino et al. [9] studies, similar results were achieved.

In our study, probiotic supplement contained Lactobacillus rhamnosus, Lactobacillus reuteri, Bifidobacterium infantis and Fructooligosaccharide (FOS) strains which are known to have therapeutic effects against colic from a number of studies. In a study by Savino et al., the effects of Lactobacillus probiotics, after examining 45 infants with colic and 42 non-colic infants, were evaluated. The study

reported that L. Reuteri can inhibit the growth of glycogenic forms of gases in the intestines [16]. A recent study has shown that a strain of Lactobacillus root can inhibit the growth of glycogenic forms of gases in the intestine [16]. The lack of intestinal lactobacilli may seem to play a role in the pathology of colic, and it has also been shown that treatment with lactobacillus in comparison with simethicone may have a significant effect on the recovery of colic symptoms [20,21].

Although previous studies have investigated the effect on crying frequency and duration on maternal physical and mental health [3], in this study we examined the impact of lifestyle in families on the number and duration of infants crying. Considering the fact that lifestyle of individuals in both of our target groups did not differ significantly (P value ¼ 0.067), its effect on the main variables of the study was not investigated.

In a study by Shenassa and Brown, a results from six studies reported a correlation between mother's smoking and infant colic, whereas, five studies reported the contradictory results [22]. In our study, there was no significant difference in the level of exposure to cigarette smoke between two groups (P value ¼ 0.311).

Crying due to Infantile colic has a great impact on future mental and physical health. In a study by Brown et al., in 2009 on the effects of crying in infancy on the health and well-being of children at school age, it was concluded that infants who had colic had two times greater odds of reduced mental health at school-going age [5]. Therefore, infantile colic has an important impact during the infancy period and ages ahead.

Our study concludes that probiotic has significant effect on infantile colic. Probiotics are associated with a change in the microbial flora of the intestine and changes in the intestinal pH in the treatment of many intestinal diseases [23]. The colonization of beneficial bacteria in the GIT, such as lactobacillus and bifidobacterium, and the increased diversity of probiotic species, can protect children from digestive problems [18,19].

We encountered limitations in this study, such as the low number of specimens, the inaccuracy of some parents in reporting the exact duration and frequency of infant crying and discontinuation of supplementation by the mother due to the lack of results in the first week, however this led to exclusion from the study.

Ethical approval and consent to participate

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Consent to participate: from the under 16 years old was given by a parent or legal guardian.

Consent for publication Not applicable.

Availability of data and material

Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.

Funding source

No funding was secured for this study.

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