Colic, Irritability, Reflux, Intolerance and Allergy Study (CIRIAS): A Randomised Controlled Trial of maternal dietary interventions in breastfeeding mothers with colicky infants

Not Applicable

• Conditions: Colic; Reflux; Atopy; Food Allergy; Food Intolerance; Reproductive Health and Childbirth - Breast feeding; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12612000773831
• Lead Sponsor: niversity of Queensland, School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Mothers must be exclusively feeding their infant aged 0-4 months
Infants must be experiencing 'colic' and/or associated symptoms of food allergy/intolerance such as reflux, atopy, vomitting, diarohea

Exclusion Criteria

The following exclusion criteria have been developed to ensure that both mother and infant participating in this study are otherwise well and healthy. Mothers who are experiencing post natal deperession will be ineligible to participate, a pre-screening process is insitu for the assessment of PND.

In addition, infants that are unwell or under medical investigation for underlying pathology associated with their 'colic' will be deemed ineligible to participate. This is assessed through a 'medical clearance to participate' visit to their family GP for the infant. Infants without medical clearance will be ineligible to participate in this project. Infants whose crying is assessed as not 'colicky' through the pre-screening process will also be deemed ineligible to participate. this pre-screening process has been developed to ensure that participating infants fulfill the medical criteria for infant colic.

Study & Design

• Study Type: Interventional
• Study Design: Not specified