Baby Biotics: Do probiotics help crying babies and their families?

Completed

• Conditions: Infant colic; Pregnancy and Childbirth; Colic

• Registration Number: ISRCTN95287767
• Lead Sponsor: Murdoch Childrens Research Institute (MCRI) (Australia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Infants less than 3 months old (up to and excluding 13.0 weeks) with:
1. Infant colic, ie crying more than 3 hours/day for more than 3 days over 7 days (as defined by the modified Wessel's criteria) by caregiver's report
2. More than 36 weeks gestation at birth
3. Birth weight more than 2500 g

Exclusion Criteria

1. Infants with failure to thrive (weight gain less than 20 g/day averaged from birth to the last recorded weight)
2. Infants with major medical problems (eg. ill, immunocompromised, infants with major developmental or chromosomal abnormalities)
3. Infants or breastfeeding mothers using antibiotics or probiotics at the time of study recruitment
4. Families with insufficient English to understand informed consent or complete questionnaires

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean infant crying time (minutes per 24 hours), measured by the Barr diary, a validated measure of infant crying, at 28 days