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Manipulating the diet of breastfeeding mothers to relieve the symptoms of infantile colic: A randomised controlled double blinded crossover study.

Manipulating the diet of breastfeeding mothers to relieve the symptoms of infantile colic: A randomised controlled double blinded crossover study.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000512426
Enrollment
13
Registered
2016-04-20
Start date
2014-09-26
Completion date
2016-02-26
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

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.

Interventions

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

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.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Exclusively breastfeeding mothers. with Infants <9 weeks of age. All participants with ther infants, need to meet the "Wessel criteria' for colic

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,

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026