Preventive effects of synbiotic oral supplementation on infant colic: a prospective randomized clinical trial study

The preventive effects of oral synbiotics consumption on infant colic

Randomized clinical trial with control group, double-blind, randomized, on 51 patients, RAS software was used for randomization.

Infants in Tehran Children's Clinic, if eligible, and if their parents wish to cooperate and complete a written informed consent, will be included in the study. Before allocating the study subjects to intervention and placebo groups, height, weight and head circumference will be measured . Information related to the individual characteristics of the baby and the parent and then the mother's quality of life questionnaire will be collected from them .Stool samples will be taken from all infants studied at the beginning and end of the study to measure calprotectin .Also, synbiotic and placebo supplements will be given in the same packages to the infants of the two groups in a double-blind manner; And the researcher and the subjects will be blind to the grouping.

Inclusion criteria: Birth age 37 to 42 weeks; weight above 2000, visiting the clinic under 10 days Exclusion criteria: Taking antibiotics and probiotics before the study; Initial hospitalization or re-hospitalization; congenital; immune; metabolic and developmental defects; sensitivity to gluten; cow's milk protein or any substance in placebo or synbiotic syrup and lactose intolerance; Abdominal pain; probiotic consumption by mothers

The intervention group will receive 10 drops of synbiotic supplement daily, and placebo group will receive the same supplement without the active ingredient, completely similar to the intervention group in terms of appearance, color, and smell, for 8 weeks.

Quality of life of mothers; fecal levels of calprotectin

The studied subjects will be blocked based on their weight (less than or more than 2500 grams) and type of nutrition (exclusive breastfeeding or not), and then they will be randomly divided into two intervention groups with synbiotic and placebo. 51 Subjects were assigned to intervention and placebo groups by block randomization using RAS statistical software (Random Allocation Software: RAS) (size 4), and infants were placed in blocks of 4 based on weight and feeding type. In this study, the participants are randomly placed in two intervention and placebo groups so that the researchers can compare the effects of the supplement in the two groups. Researchers and participants cannot arbitrarily play a role in assigning people to groups. Random assignment of people to the intervention or placebo group will be done by an experienced expert

All subjects and researchers and healthcare personnel who are responsible for the care of patients will be unaware of the existing grouping until the end of the study; In this way, researchers and doctors, like the study participants, are unaware of which patients receive synbiotic supplements or placebo. Patients are also unaware of the type of supplement received. Drugs and placebos are coded by a person who is completely unaware of the study process, and this code is placed in an envelope that indicates whether it is a drug or a placebo code. One group will receive drug A and one group will receive drug B. Also, the synbiotic and placebo supplement, which has the same color, smell, and size as the supplement, will be studied by another person who has no knowledge of the research process once in 4 weeks at the hands of the parents of babies. Hence, this study will be a double-blind study.The placebo supplement contains all the ingredients of the product except the active ingredient, and it is completely similar to the synbiotic supplements in terms of color, appearance and smell. The placebo supplement is also prepared by the same manufacturing company as the synbiotic supplement