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Trial registered on ANZCTR


Registration number
ACTRN12616000512426
Ethics application status
Approved
Date submitted
12/04/2016
Date registered
20/04/2016
Date last updated
29/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Manipulating the diet of breastfeeding mothers to relieve the symptoms of infantile colic: A randomised controlled double blinded crossover study.
Scientific title
Manipulating the diet of breastfeeding mothers to relieve the symptoms of infantile colic: A randomised controlled double blinded crossover study.
Secondary ID [1] 288985 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infantile colic 298386 0
Condition category
Condition code
Diet and Nutrition 298489 298489 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 298505 298505 0 0
Breast feeding
Reproductive Health and Childbirth 298506 298506 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The low FODMAP diet refers to Fermentable, Oligosaccharides, Disaccharides, and Monosaccharides and Polyols. These are short-chain carbohydrates that may be slowly digested or indigestible, and can lead to IBS symptoms in some adults. These FODMAPs are found in 'gas-yielding' foods and are commonly avoided by breastfeeding mothers during the time of lactation, for a more settle baby. Foods that contain, fructose in excess of glucose (eg. Apples, honey), fructans and/or galacto-olicosaccharides (eg. garlic, onion, legumes, wheat as a major ingredient), lactose (cow's milk, yoghurt, ice-cream) and polyols, sorbitol (eg. avocado, artificial sweeteners) and mannitol (eg. mushrooms, watermelon), Alternative low FODMAP options are provided. eg bananas, strawberries, orange for fruit, green beans, carrots, capsicum for vegetables, and lactose-free dairy products and hard cheese. Participants will receive adequate food to meet their energy requirements (kJ), based on their estimated energy requirements (including extra 2MJ/day for lactation). The diet (10 days) is prepared and provided to all participants (from Melbourne and surrounds) by the key researcher (also a dietitian, with 9 years experience) with the assistance of qualified chefs. Breastfeeding mothers. Mothers are expected to complete daily infant baby diaries, capturing crying-fussing times, awake and sleeping times and feeding times, and a daily food diary for themselves, and provide one breast milk samples during baseline, and two during the dietary intervention (days 7 and 10 of the diet intervention)., Uneaten food containers are returned from the dry foods, uneaten portions of food products from fresh and/or frozen foods are discarded. A portable freezer is provided to participants to place samples in. All materials and food, are delivered to the home of participants and collected at the end of the study. The alternate diet is the Typical Australian Diet which is provided and prepared by the same researcher/chefs for 10 days and diaries/sample collections are also required for collection at the same time-points as the low FODMAP diet. There is no washout period between the 2 diets.
Intervention code [1] 294471 0
Lifestyle
Intervention code [2] 294531 0
Treatment: Other
Comparator / control treatment
The Typical Australian Diet (which has been validated by our department for earlier studies [1,2] ) is used as the comparator/placebo to the low FODMAP diet. This intervention is provided for 10 days.. All foods are prepared by the key researcher and qualified chefs and delivered to the home of the participants. There is no washout period between the 2 diets being provided.
References:
1) Barrett JS, Gibson PR. Development and validation of a comprehensive semi-quantitative food frequency questionnaire that includes FODMAP intake and glycemic index. J Am Diet Assoc 2010;110:1469–1476.

2) Halmos EP, Power VA, Shepherd SJ, Gibson, PR, and Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology 2014;146:67-75
Control group
Active

Outcomes
Primary outcome [1] 297975 0
Crying-fussing times (combined) assessed using validated Barr diaries (Baby Day diaries). These are completed by the breastfeeding mothers (the participants)
Timepoint [1] 297975 0
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.
Secondary outcome [1] 322806 0
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.
Timepoint [1] 322806 0
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.
Secondary outcome [2] 322993 0
Change in faecal pH will be assessed in infant faecal samples.
Timepoint [2] 322993 0
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.
Secondary outcome [3] 322994 0
Calprotectin levels will be assessed in infant faecal samples.
Timepoint [3] 322994 0
This will be done for baseline samples only.

Eligibility
Key inclusion criteria
Exclusively breastfeeding mothers. with Infants <9 weeks of age. All participants with ther infants, need to meet the "Wessel criteria' for colic
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293343 0
University
Name [1] 293343 0
Monash University
Address [1] 293343 0
No funding is received for the study. The key researcher receives a university scholarship (MPA) and materials and tools for the study are provided by the University. Central Clinical School, The Alfred Centre, Level 6/99 Commercial Rd, Melbourne, 3004, Victoria
Country [1] 293343 0
Australia
Primary sponsor type
University
Name
Monash University
Address
The Alfred Centre, Central Clinical School, Level 6/99 Commercial Rd, Melbourne 3004 Victoria
Country
Australia
Secondary sponsor category [1] 292162 0
None
Name [1] 292162 0
Address [1] 292162 0
Nil
Country [1] 292162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294811 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 294811 0
246 Clayton Road, Clayton, Melbourne, Victoria, 3168
Ethics committee country [1] 294811 0
Australia
Date submitted for ethics approval [1] 294811 0
05/03/2014
Approval date [1] 294811 0
17/04/2014
Ethics approval number [1] 294811 0
14033B

Summary
Brief summary
The aim of the project is to examine if changes in the maternal diet can reduce the colicky symptoms of infants with infantile colic, resulting in a more settled baby and reduced parental stress and exhaustion. There is limited evidence to support that changes in the mother's diet can lead to a more settled baby despite this being common practice by breastfeeding mothers and health professionals. This study will use rigorous and controlled methods to investigate if the properties of breast milk and infant faeces changes when the mother's diet is altered, which is currently unclear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65130 0
Ms Marina Iacovou
Address 65130 0
Monash University, The Alfred Centre, Central Clinical School. Level 6/99 Commercial Rd, Melbourne, Victoria. 3004
Country 65130 0
Australia
Phone 65130 0
+61399030392
Fax 65130 0
Email 65130 0
marina.iacovou@monash.edu
Contact person for public queries
Name 65131 0
Ms Marina Iacovou
Address 65131 0
Monash University, The Alfred Centre, Central Clinical School. Level 6/99 Commercial Rd, Melbourne, Victoria. 3004
Country 65131 0
Australia
Phone 65131 0
+61399030392
Fax 65131 0
Email 65131 0
marina.iacovou@monash.edu
Contact person for scientific queries
Name 65132 0
Ms Marina Iacovou
Address 65132 0
Monash University, The Alfred Centre, Central Clinical School. Level 6/99 Commercial Rd, Melbourne, Victoria. 3004
Country 65132 0
Australia
Phone 65132 0
+61399030392
Fax 65132 0
Email 65132 0
marina.iacovou@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary