Manipulating the diet of breastfeeding mothers to relieve the symptoms of infantile colic: A randomised controlled double blinded crossover study.

Completed

• Conditions: Infantile colic; Diet and Nutrition - Other diet and nutrition disorders; Reproductive Health and Childbirth - Breast feeding; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12616000512426
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Exclusively breastfeeding mothers. with Infants <9 weeks of age. All participants with ther infants, need to meet the Wessel criteria' for colic

Exclusion Criteria

Infants older than 9 weeks without a diagnosis of infantile colic, receiving a combination of breast milk and formula, or formula-fed alone,

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Crying-fussing times (combined) assessed using validated Barr diaries (Baby Day diaries). These are completed by the breastfeeding mothers (the participants)[Baseline period is 7 days. Two diets will be provided,, each of them for 10 days (20 days total). There is no follow up on completion of the study. Diaries will be completed on a daily basis for each phase of the study.<br>]

Secondary Outcome Measures

Name	Time	Method
A change in breast-milk composition of short-chain carbohydrates (Fructose, polyols, fructans, galacto-oligosacchrides and lactose) will be assessed using HPLC and UPLC methods. [For each participant - this will be done for one sample of breast milk at baseline, and for samples collected on days 7 and 10 of each study diet. A total of 5 samples.];Change in faecal pH will be assessed in infant faecal samples. [For each participant - this will be assessed in one sample at baseline, and on days 7 and 10 of each of the two study diets. A total of 5 samples.];Calprotectin levels will be assessed in infant faecal samples.[This will be done for baseline samples only.]