Synbiotic Therapy in Infantile Colic - A Clinical Trial Volume 4 - Issue 3
Peymaneh Alizadeh Taheri1*, Armen Malekian Taghi2 and Mandana Motevaselian3
*1Department of Neonatology, Tehran University of Medical Sciences, Bahrami Children Hospital, Tehran, Iran
2Department of Gastroenterology, Tehran University of Medical Sciences, Bahrami Children Hospital, Tehran, Iran
3Department of Pediatrics, Tehran University of Medical Sciences, Bahrami Children Hospital, Tehran, Iran
Received:May 19, 2023 Published: May 26, 2023
Corresponding author:Peymaneh Alizadeh Taheri, Department of Neonatology, Tehran University of Medical Sciences, Bahrami
Children Hospital, Tehran, Iran
Background: Infantile colic is a common referral problem to pediatric clinics. The last criteria for the diagnosis of colic are the
Rome IV criteria. There are different recommendations for the treatment of infantile colic but the response to each treatment is
variable and no definite treatment has been recognized for this problem yet.
Aims: According to our last research, few clinical trials have surveyed the efficacy of synbiotics containing multi-strain probiotics
in infantile colic, so the present study was performed.
Material and Methods: This study was performed on 60 infants (65% boys, mean age 62.26±15.6 days; mean birth weight:
3150±420 g) with the diagnosis of infantile colic. The infants of group A were randomly administered a synbiotic containing B.
infantis, L. reuteri, L. rhamnosus, and fructooligosaccharides (FOS) (PediLact® [Zist-Takhmir Co., Tehran, Iran] drop), while group
B received placebo (Dimeticon) [Toliddaru Co., Tehran, Iran]). The primary outcome was the response rate of each group, and the
secondary outcome was the adverse effect of each drug.
Results:The response rate to the synbiotic containing multi-strain probiotics was significant after each week of intervention
to the fourth week of intervention (Intragroup P-value <0.001). The response rate was also significant in synbiotic group after each
week of intervention to the fourth week of intervention (Intergroup P-value <0.001) in comparison with Dimeticon. There was no
adverse effect through each intervention.