Infantile colic is an “irritable/uncontrollable/compulsive/inconsolable crying” for more than 3 hours a day, at least for three days a week, and for a week or longer in an infant without any distinct cause or failure to thrive. The onset and impoverishment of the symptoms must occur under 5 months of age in order for the condition to be definite as infantile colic.. Functional intestinal disorder, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Mothers who receive probiotics:87 pregnant mother at the last 4 weeks of pregnancy enter to the study. The probiotic drug (containing 100 million live L. Reuteri fr
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: The last 4 weeks of pregnancy The absence of a history of maternal immunocompromising conditions such as HIV The absence of maternal diabetes, hepatic and renal diseases, anemia (hemoglobin less than 10), bacterial or fungal infections, twins, maternal smoking history of 10 cigarettes per day, or administration of other probiotics Maternal age between 18 and 49 years old All pregnant mothers who have informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Mother hypersensitivity to any component of drug Mothers who are not willing to continue pregnancy or who have had an early pregnancy due to complications of pregnancy Preterm labor Mothers who do not receive the drug properly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of colic. Timepoint: From birth to 5 months. Method of measurement: For the assessment colic severity, we used a validated Iranian questionnaire previously suggested by Famoori et al.;Infantile colic and severity. Timepoint: From birth to 5 months. Method of measurement: ?Defined by Wessel et al. and modified by ROME IV criteria as “irritable/uncontrollable/compulsive/inconsolable crying” for more than 3 hours a day, at least for three days a week, and for a week or longer in an infant without any distinct cause or failure to thrive. The onset and impoverishment of the symptoms must occur under 5 months of age in order for the condition to be definite as infantile colic. | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevention or reduction of severity of infantile colic. Timepoint: Birth to 5 months. Method of measurement: questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Fateme Famoori
Esfahan University of Medical Sciences
Outcome results
None listed