The Comparison of two synbiotics in the treatment of infantile colic

Phase 2

• Conditions: R 10.4; Infantile colic.; Abdominal pain

• Registration Number: IRCT20160827029535N4
• Lead Sponsor: Investigator

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1-Breast-fed infants with the age of 3 weeks to 3 months 2- Fulfilling the Wessel’s criteria including: crying for at least 3 hours per day, for at least 3 days per week, and for at least 3 weeks from birth to 3-4 months of age or the characteristic clinical manifestations of colic including irritability, crying ,flushing and passage of a large amount of bowel gas along with defecation; irritability and crying especially in the evening and increased bowel sounds in auscultation 3-No failure to thrive .

Exclusion Criteria

1-any acute or chronic diseases, especially GI tract conditions
2- use of medications except routine supplements

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate of infantile colic symptoms and signs. Timepoint: Before intervention, one week and one month after beginning of intervention. Method of measurement: Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Complications of each synbiotic during intervention including vomiting, constipation, skin reactions and infections. Timepoint: Before intervention,one week and one month after intervention. Method of measurement: Questionnaire.