Reducing the maternal dietary intake of indigestible and slowly absorbed short-chain carbohydrates is associated with improved infantile colic: a proof-of-concept study

Not Applicable

Completed

• Conditions: Infantile colic; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12613000790741
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Infants <6 months, exclusively breast-fed, diagnosed with infantile colic according to Wessel criteria, with no underlying medical conditions or on medications, otherwise healthy typically developing infants. Mothers 18-45 years of age, with no underlying medical conditions or on medications.

Exclusion Criteria

Infants >6 months with medical condition/on medication. Mothers with medical condition/on medication. <18 years of age >45 years of age

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in crying times. This will be assessed using a validated record chart (Barr Diary) where parent's will be recording infant's crying and fussing times (stopwatch provided and record charts provided) at baseline for a total of 3 days and also on days 5,6 and 7 while on the study diet (The low FODMAP diet). [Baseline and seven days. ]

Secondary Outcome Measures

Name	Time	Method
Breast milk samples will undergo HPLC analyses for short-chain carbohydrates (FODMAPs) and will also be tested at CSIRO for bacteria composition - these tests will be performed for both baseline and intervention samples.[Baseline and seven days.];Changes in faecal samples. Descriptive information will be sourced from the mother regarding infant faecal frequency, consistency and colour. Photographs will also be taken by mothers prior to collection of faecal samples (collected using specific stool specimen containers). pH tests will also be performed on all faecal samples at baseline and at day six-seven of intervention.[Baseline and at seven days]