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The comparison of the efficacy of a synbiotic drop with dimeticone drop in the treatment of infantile colic

Not Applicable
Recruiting
Conditions
Infantile colic.
Indeterminate colitis
K52.3
Registration Number
IRCT20160827029535N6
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
70
Inclusion Criteria

Any healthy infant
Under 5 months of age
Diagnosed as colic according to the new Rome IV criteria

Exclusion Criteria

Any acute or chronic diseases, especially GI tract conditions
Taking antibiotics or supplements of probiotics or prebiotics since 1 week prior to the study
Not fulfilling the new Rome IV criteria
Parents' unwilling to participate in the study.
Protein milk allergy

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Recovery rate of infantile colic symptoms and signs. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire.;Complications of each drug during intervention. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire.
Secondary Outcome Measures
NameTimeMethod
Recovery rate of infantile colic symptoms and signs. Timepoint: One week one month after beginning of intervention. Method of measurement: Questionnaire.;Complications of each drug ( diarrhea, vomiting and skin rush) during intervention. Timepoint: One week and one month after intervention. Method of measurement: Questionnaire.
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