ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1132-1252

Trial acronym

CIRIAS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Colic

Reflux

Atopy

Food Allergy

Food Intolerance

Condition category

Condition code

Reproductive Health and Childbirth

Breast feeding

Oral and Gastrointestinal

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]

Behaviour

Intervention code [2]

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]

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]

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]

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]

Measured daily by mothers/carers completing toileting charts, daily until the end of this study, a total of 4 weeks duration.

Secondary outcome [1]

1) Prevalence of food allergy among this cohort

Timepoint [1]

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]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland, School of Medicine

Address [1]

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]

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]

University

Name [1]

University of Queensland, School of Medicine, Children's Nutrition Research Centre

Address [1]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UQMREC

Ethics committee address [1]

University of Queensland
Medical Ethics Research Committee
Stewart-Cambrea Building
St Lucia QLD 4067

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/05/2012

Ethics approval number [1]

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

Ms Tracy Harb

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

Phone

+61 407381691

Fax

t.harb@uq.edu.au

Contact person for public queries

Name

Tracy Harb

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

Phone

+61 407381691

Fax

+61 733464684

t.harb@uq.edu.au

Contact person for scientific queries

Name

Tracy Harb

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

Phone

+61 407381691

Fax

+61 733464684

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

Source	Title	Year of Publication	DOI
Embase	Is sensory processing an issue for infants with colic?.	2017	https://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.

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Documents added manually

Documents added automatically