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Trial registered on ANZCTR


Registration number
ACTRN12612000773831
Ethics application status
Approved
Date submitted
20/07/2012
Date registered
20/07/2012
Date last updated
16/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Colic, Irritability, Reflux, Intolerance and Allergy Study (CIRIAS): A Randomised Controlled Trial of maternal dietary interventions in breastfeeding mothers with colicky infants
Scientific title
Colic, Irritability, Reflux, Intolerance and Allergy Study (CIRIAS): A Randomised Controlled Trial of maternal dietary interventions in breastfeeding mothers on changes in crying duration and intensity in infants colic.
Secondary ID [1] 280736 0
None
Universal Trial Number (UTN)
U1111-1132-1252
Trial acronym
CIRIAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colic 286558 0
Reflux 286559 0
Atopy 286560 0
Food Allergy 286561 0
Food Intolerance 286562 0
Condition category
Condition code
Reproductive Health and Childbirth 286826 286826 0 0
Breast feeding
Oral and Gastrointestinal 287146 287146 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284942 0
Behaviour
Intervention code [2] 285157 0
Treatment: Other
Comparator / control treatment
The control group will now comprise mothers of infants prescribed and commencing a medication for suspected reflux
The intervention groups (2 & 3) will receive maternal dietary modification only
Control group
Active

Outcomes
Primary outcome [1] 287191 0
Primary Outcome 1): changes in crying duration and intensity in infants aged 0-4 months. Mothers are required to complete a series of paper based tools for recording their infant's crying, fussiness. The crying diaries are a modified Barr Baby Diary, this has been extensively validated in research. Crying diaries are kept for 3 consecutive days in weeks 1-3 and daily in week 4.
Timepoint [1] 287191 0
Measured at baseline (pre intervention) 3 consecutive days in week 0
Measured again in weeks 1 & 2 (1st & 2nd weeks of intervention) on 3 consecutive days
Measured again in week 3 (reintroduction of eliminated foods) on 7 consecutive days
Primary outcome [2] 287192 0
Primary Outcome 2): Changes in bowel motions of infants aged 0-4 months. Mothers are required to track thier infant's toileting habits daily for the duration of their involvement with this project, a total of 4 weeks. This chart is based on the Amsterdam Infant Stool Chart, which has been extensively validated through research.
Timepoint [2] 287192 0
Measured daily by mothers/carers completing toileting charts, daily until the end of this study, a total of 4 weeks duration.
Secondary outcome [1] 297587 0
1) Prevalence of food allergy among this cohort
Timepoint [1] 297587 0
Allergy status of mothers and their infants will be assessed through blood sampling and analysis, at the beginning of their particiaption in this study; and through Atopy Patch Testing at the end of their participation in this study
Secondary outcome [2] 297588 0
2) Prevalence of food intolerance among this cohort, as assessed by the effects on the infant (toileting and crying) of the reintroduction of the eliminated foods in the maternal diet.
Timepoint [2] 297588 0
This is assessed in the dietary intervention groups through the reintroduction of foods in week 3

Eligibility
Key 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
Minimum age
0 Days
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will self-refer. Randomisation will occur after the consent and pre-screening processes are completed.

The allocation concealment was acheived by central randomisation by computer. The primary invesitgator is blinded to the randomisation process. The enrolled participants will be blinded to the details of the other treatment groups, this is imperative as it reduces the effect of bias in this study.

Randomisation is achieved through 'Block Randomisation', which is done by the investigator's primary supervisor. The participants continue to be blinded to the details of the other treatment group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is achieved through 'Block Randomisation', which is done by the investigator's primary supervisor. The participants continue to be blinded to the details of the other treatment group. A total of 69 participants is required for this new protocol
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The researcher will be blinded to the randomisation process, however, the researcher (an accredited practising dietitian) is required to educate the participants on theri specific dietary intervention, so she will not be blinded to the participants in each group. The Participants will be blinded to other participants in other treatment groups. This research involves maternal dietary manipulation to determine its effects on the gastrointestinal/immune system of their exclusively breastfed infants aged 0-4 months.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/07/2012
Actual
13/11/2013
Date of last participant enrolment
Anticipated
Actual
19/11/2015
Date of last data collection
Anticipated
Actual
20/12/2015
Sample size
Target
69
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD

Funding & Sponsors
Funding source category [1] 285323 0
University
Name [1] 285323 0
University of Queensland, School of Medicine
Country [1] 285323 0
Australia
Primary sponsor type
University
Name
University of Queensland, School of Medicine
Address
Children's Nutrition Research Centre
UQ Child Health Research Centre I Faculty of Medicine
The University of Queensland
Level 6 Centre for Child Health Research
Graham Street
SOUTH BRISBANE QLD 4101
Country
Australia
Secondary sponsor category [1] 284358 0
University
Name [1] 284358 0
University of Queensland, School of Medicine, Children's Nutrition Research Centre
Address [1] 284358 0
Children's Nutrition Research Centre
UQ Child Health Research Centre I Faculty of Medicine
The University of Queensland
Level 6 Centre for Child Health Research
Graham Street
SOUTH BRISBANE QLD 4101
Country [1] 284358 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287533 0
UQMREC
Ethics committee address [1] 287533 0
University of Queensland
Medical Ethics Research Committee
Stewart-Cambrea Building
St Lucia QLD 4067
Ethics committee country [1] 287533 0
Australia
Date submitted for ethics approval [1] 287533 0
Approval date [1] 287533 0
01/05/2012
Ethics approval number [1] 287533 0

Summary
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.
Trial website
http://www.som.uq.edu.au/cnrc/cirias

This website is password protected, all participants will be emailed their password in order for them to access this website and allt eh study materials contained there.
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34227 0
Ms Tracy Harb
Address 34227 0
Children's Nutrition Research Centre
UQ Child Health Research Centre I Faculty of Medicine
The University of Queensland
Level 6 Centre for Child Health Research
Graham Street
SOUTH BRISBANE QLD 4101
Country 34227 0
Australia
Phone 34227 0
+61 407381691
Fax 34227 0
Email 34227 0
t.harb@uq.edu.au
Contact person for public queries
Name 17474 0
Ms Tracy Harb
Address 17474 0
Children's Nutrition Research Centre
UQ Child Health Research Centre I Faculty of Medicine
The University of Queensland
Level 6 Centre for Child Health Research
Graham Street
SOUTH BRISBANE QLD 4101
Country 17474 0
Australia
Phone 17474 0
+61 407381691
Fax 17474 0
+61 733464684
Email 17474 0
t.harb@uq.edu.au
Contact person for scientific queries
Name 8402 0
Ms Tracy Harb
Address 8402 0
Children's Nutrition Research Centre
UQ Child Health Research Centre I Faculty of Medicine
The University of Queensland
Level 6 Centre for Child Health Research
Graham Street
SOUTH BRISBANE QLD 4101
Country 8402 0
Australia
Phone 8402 0
+61 407381691
Fax 8402 0
+61 733464684
Email 8402 0
t.harb@uq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIs sensory processing an issue for infants with colic?.2017https://dx.doi.org/10.1016/j.infbeh.2017.05.003
N.B. These documents automatically identified may not have been verified by the study sponsor.