None listed
Conditions
Brief summary
The study aims to investigate the association between maternal diet and colic, irritability, reflux, atopy and gastrointestinal dysfunction in exclusively breast-fed infants aged zero to four months; and to develop an evidenced based treatment algorithm for the non-invasive treatment of colic and associated symptoms in infants. A series of hypotheses have been developed for this study, these include. H1: Food allergy contributes significantly to persistent infant colic and other symptoms of allergic disease in exclusively breast fed infants. Thereby, eliminating major contributors to food allergy, specifically CMP and hen’s egg from the maternal diet significantly reduces persistent infant colic and other symptoms suggestive of protein specific food allergies in exclusively breast fed infants aged birth to four months. H2: Food intolerance contributes significantly to persistent infant colic in infants aged birth to four months. Eliminating major contributors to food intolerance, specifically, high FODMAP foods from the maternal diet significantly reduces persistent infant colic and other symptoms suggestive of food intolerance in exclusively breast fed babies. H3: The Vitamin D status of the mother and infant affects the predisposition to food allergy/intolerance in exclusively breast-fed infants aged birth to four months. H4: Breast milk composition with regard to microbiota profile is associated with allergy in infants aged birth to four months. H5: Sensory processing disorders (sensory hypersensitivity) contributes to infant colic.
Interventions
There are 3 intervention arms to this RCT:
1) Control - infants who have been prescribed and commence medications for suspected reflux
2) Maternal elimination diet (food allergy), which involves eliminating 2 food proteins from the maternal diet for a period of 2 weeks only, the eliminated foods will be re-introduced in the week following dietary elimination, food frequency questionnaires will be completed by participants to test for compliance to the elimination diet.
3) Maternal elimination di
There are 3 intervention arms to this RCT: 1) Control - infants who have been prescribed and commence medications for suspected reflux 2) Maternal elimination diet (food allergy), which involves eliminating 2 food proteins from the maternal diet for a period of 2 weeks only, the eliminated foods will be re-introduced in the week following dietary elimination, food frequency questionnaires will be completed by participants to test for compliance to the elimination diet. 3) Maternal elimination diet (food intolerance), which involves eliminating highly fermentable carbohydrate foods for a period of 2 weeks only, the eliminated foods will be re-introduced in the week following dietary elimination, food frequency questionnaires will be completed by participants to test for compliance to the elimination diet.
Sponsors
University of Queensland, School of Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 4 Months
Healthy volunteers
Yes
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.
Outcome results
None listed