Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000790741
Ethics application status
Approved
Date submitted
25/06/2013
Date registered
15/07/2013
Date last updated
30/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing the maternal dietary intake of indigestible and slowly absorbed short-chain carbohydrates is associated with improved infantile colic: a proof-of-concept study
Scientific title
Reducing the maternal dietary intake of indigestible and slowly absorbed short-chain carbohydrates is associated with improved infantile colic: a proof-of-concept study
Secondary ID [1] 282733 0
Nil
Universal Trial Number (UTN)
U1111-1145-0035
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infantile colic 289467 0
Condition category
Condition code
Oral and Gastrointestinal 289780 289780 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 289781 289781 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The low FODMAP diet (a nutritive oral diet therapy, for the mother) will be provided to investigate if there is any relief of colicky symptoms such as wind/gas, drawing up of knees, back arching, excessive fussing and crying. The low FODMAP diet refers to Fermentable, oligo-, di-, mono-saccharides and polyols (short chain carbohydrates) which are commonly malabsorbed by the gut and in some people problematic, leading to symptoms such as abdominal pain, wind/gas, distension, altered bowel habits of diarrhoea, constipation or both. The low FODMAP diet reduces the intake of such carbohydrates which are shown to reduce the symptoms in up to 80% of adults and this diet is being trialled on infants who are colicky and unsettled, who display similar symptoms to adults with IBS. The diet consists of various foods from all the main food groups and is a well balanced nutritious diet meeting the energy requirements of a breast feeding mother - all foods (meals and snacks) are provided for consumption by the mother, for a period of seven days by the researcher who is also an accredited practicing dietitian (APD). Adherence is monitored by food diaries however 100% compliance is guaranteed if the participants only consume foods that have been provided for the intervention period of seven days.
Intervention code [1] 287396 0
Treatment: Other
Comparator / control treatment
Participants act as their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289866 0
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).
Timepoint [1] 289866 0
Baseline and seven days.
Secondary outcome [1] 303424 0
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.
Timepoint [1] 303424 0
Baseline and seven days.
Secondary outcome [2] 303637 0
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.
Timepoint [2] 303637 0
Baseline and at seven days

Eligibility
Key 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.
Minimum age
0 Days
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will receive the intervention treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will not be randomised
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired t-tests will be used to compare baseline and intervention data - based on previous pilot studies in our department we have found that 15 participants are needed to achieve study objectives.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2013
Actual
18/02/2013
Date of last participant enrolment
Anticipated
29/11/2013
Actual
23/04/2014
Date of last data collection
Anticipated
Actual
5/05/2014
Sample size
Target
18
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1161 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 287512 0
University
Name [1] 287512 0
Monash University
Country [1] 287512 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 6/99 Commercial Road, Melbourne, Vic 3004
Country
Australia
Secondary sponsor category [1] 286253 0
None
Name [1] 286253 0
None
Address [1] 286253 0
None
Country [1] 286253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289486 0
Monash Health
Ethics committee address [1] 289486 0
Research Directorate
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Ethics committee country [1] 289486 0
Australia
Date submitted for ethics approval [1] 289486 0
Approval date [1] 289486 0
19/05/2010
Ethics approval number [1] 289486 0
10087B

Summary
Brief summary
Infantile colic is estimated to affect 25% of infants and occurs equally in breast-fed and formula-fed infants. Infantile colic increases the risk of post-natal depression, shaken baby syndrome and the cessation of breastfeeding. Therapeutic approaches have included changing infant formulae or the diet of nursing mohters however scientific evidence to support advice is lacking. Infantile colic presents with similar symptoms to adults with IBS. The low FODMAP diet is the only dietary approach with a high level of evidence for efficacy in adults (75%-80%) and hence this study hypothesizes that a low FODMAP diet (short-chain CHO's) in the diet of breast-feeding mothers of infants with colic will reduce the no. & duration of crying episodes.

Trial website
Trial related presentations / publications
Study has been submitted for publication
Public notes

Contacts
Principal investigator
Name 41038 0
Dr Jane Muir
Address 41038 0
Monash University, Central Clinical School
Gastroenterology Department
Head of Translational Nutrition
Level 6/99 Commercial Rd
Melbourne, Vic 3004
Country 41038 0
Australia
Phone 41038 0
+61 3 9903-0274
Fax 41038 0
Email 41038 0
[email protected]
Contact person for public queries
Name 41039 0
Ms Marina Iacovou
Address 41039 0
Monash University, Central Clinical School
Gastroenterology Department
PhD Candidate
Level 6/99 Commercial Rd
Melbourne, Vic 3004
Country 41039 0
Australia
Phone 41039 0
+61 03 99030392
Fax 41039 0
Email 41039 0
[email protected]
Contact person for scientific queries
Name 41040 0
Ms Marina Iacovou
Address 41040 0
Monash University, Central Clinical School
Gastroenterology Department
PhD Candidate
Level 6/99 Commercial Rd
Melbourne, Vic 3004
Country 41040 0
Australia
Phone 41040 0
+61 03 99030392
Fax 41040 0
Email 41040 0
[email protected]

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
No additional documents have been identified.