The effect of pedilact and sucrose in the treatment of infantile colic

Phase 2

Recruiting

• Conditions: Infantile colic.; Other and unspecified abdominal pain; R10.4

• Registration Number: IRCT20230625058574N1
• Lead Sponsor: Sabzevar University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Term and healthy infants between 1 and 5 months
Exclusive breastfeeding
Colic diagnosis based on ROME 4 criteria
Failure to diagnose severe acute or chronic disease
Failure to diagnose reflux or gastrointestinal malformation
No history of lactose intolerance
No history of smoking in the mother during pregnancy

Exclusion Criteria

Taking antibiotics or probiotics from one week before the study
Unwillingness to continue participating in the study for any reason
Migration from the study area

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of hours the infant sleeps per day. Timepoint: At the beginning of the study (before the start of the intervention) and 14 and 21 days after the intervention. Method of measurement: Check list.;Colicky crying hours per day. Timepoint: At the beginning of the study (before the start of the intervention) and 14 and 21 days after the intervention. Method of measurement: Check list.;Number of feeding times per day. Timepoint: At the beginning of the study (before the start of the intervention) and 14 and 21 days after the intervention. Method of measurement: Check list.