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Reducing the maternal dietary intake of indigestible and slowly absorbed short-chain carbohydrates is associated with improved infantile colic: a proof-of-concept study

Reducing the maternal dietary intake of indigestible and slowly absorbed short-chain carbohydrates is associated with improved infantile colic: a proof-of-concept study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000790741
Enrollment
18
Registered
2013-07-15
Start date
2013-02-18
Completion date
2014-04-23
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
0 to 6 Months
Healthy volunteers
No

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.

Exclusion criteria

Infants >6 months with medical condition/on medication. Mothers with medical condition/on medication. <18 years of age >45 years of age

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026