06 December 2018
Infantile colic is often treated with the use of diet. In breastfed infants with colic a very common approach is for the breastfeeding mother to remove ‘gassy’ foods. As mentioned in Part 1 this includes foods such as onion, garlic, cabbage, cauliflower and legumes/pulses – all of which are high in FODMAPs. Whilst this has been a common approach for many years, up until recently the evidence supporting this diet has been based on observational studies and have not involved testing its use in an intervention setting. This blog will provide some insights into the history of the work exploring the hypothesis that removing gassy foods from the maternal diet improves infantile colic.
It all started as an academic honours project almost 10 years ago and as an exploration study. In that study, five breastfeeding mothers of infants with colic were recruited and were provided with a low FODAMP diet. This was done by providing mothers with all their meals and beverages for seven days, which were prepared and cooked in a commercial kitchen. Each baby’s crying-fussing patterns were compared prior to commencing the diet with that at the end of the diet and assessed if there were any significant changes. What we found was unexpected. In all the babies, crying-fussing times reduced significantly – on average a reduction of 75 minutes per day. Despite infantile colic resolving over the course of 3-4 months, the improvements were much greater than anticipated in such a short time.
Previous studies have indicated that a change in crying-fussing times greater than 25% is considered clinically significant and the results of this small study showed a change of 35%.
Although the initial study was small the results were interesting, and it did raise the question – Was this one big ‘placebo’ effect?’ - meaning that when someone is knowingly provided with a treatment strategy or a level of support this induces a psychological conception (or misconception) that what they are being provided with will help them - creating a belief in the treatment. This led to a PhD project to understand if a ‘placebo effect’ really was at play or whether there was a clear association.
Firstly, as in all infantile colic studies, it was essential to ensure that there were no underlying medical conditions or other causes for a baby’s inconsolable crying-fussing patterns. Secondly, it was also essential that the diets that were provided contained dairy, allergenic foods (i.e., soy, wheat, nuts, fish, dairy and eggs), gluten and natural food chemicals. All of which have been considered as possible triggers for an unsettled baby. The mechanisms of action for such triggers however are not understood and lack evidence.
In the follow up study, a single-blinded pilot study, 18 breastfeeding mothers and their colicky babies were recruited. The mothers were blinded to the nature of the diet and again all meals and beverages were prepared and provided for seven days. In that study, a number of analyses were performed to explore if there were any changes to the breast milk or the baby’s poo as a result of changing the mother’s diet – this work was exploratory in nature in pursuit of the ‘how?’ question if in fact infantile colic symptoms improved as a result of diet.
The outcomes of the pilot study found that:
• Crying-fussing times again reduced significantly and greater than anticipated in one-week by an average of 73 minutes and a change of 30%
• Despite lactose not present in the mother’s diet, there was no change in breast milk lactose content
• Dietary FODMAPs did not enter breast milk
• Unidentified compounds in the breast milk markedly changed following a low FODMAP diet
Even though participants were 100% compliant to the dietary intervention and the magnitude and speed of benefit being impressive, a firm conclusion of the effectiveness of the diet could not be made. The question of a placebo effect and the natural resolution of infantile colic remained as major confounding factors.
Only a well-powered randomised controlled trial where both mothers and researcher are blinded to the dietary interventions would truly address this issue.
The next study was a randomised controlled clinical trial that was double-blinded and a crossover-study of two dietary interventions. A control group without colic was also observed in unison with the colic study. Following is a brief outline of the methods, results and next steps.
Methods and selection criteria:
Two 10-day maternal study diets were provided – each participant was randomly assigned to one diet first then crossed-over to the alternate diet
In total, 27 mother-baby pairs were recruited. Of these 13 from the colic group and 7 from the non-colic group had complete evaluable data to analyse. While these numbers may seem small, in the world of science applying a statistical analysis against the study design found that the number of mother-baby pairs were deemed acceptable to establish conclusions. Despite 180 mother-baby pairs being assessed for entry into the study, the majority did not meet the study’s selection criteria.
What were the findings:
The low FODMAP diet was associated with a clinically significant improvement in the baby’s crying-fussing times. This was not attributed to the babies being ‘over-tired’ or ‘hungry’, which may be considered reasons for a crying-fussing baby, as sleeping patterns remained stable and baby awake times increased.
Although in the colic group maternal stress and anxiety was greater than the non-colic group, levels were still within normal range. Though it does suggest a colicky infant can lead to increased stress and anxiety in a breastfeeding mother. In this study, stress and anxiety was higher in the low FODMAP diet at a time when babies were more settled further suggesting that the colic was not a trigger for the stress and anxiety of the mother.
The selection criteria and providing all the foods were major study-strengths as it meant that no other confounding factors could give rise to the outcomes. Although a placebo-effect and the natural resolution of colic can now be excluded as reasons the benefits of a maternal low FODMAP diet, the next unanswered question is ‘how does the low FODMAP diet work?’
The answer may be in the bacterial changes in the mother’s gut, changes in the compounds of the breast milk, or both. This is the next exciting puzzle of the jigsaw that we are trying to solve.
For anyone wanting to use dietary therapy as a treatment for infantile colic please see your doctor for advice and a qualified dietitian.
I wish to acknowledge and thank all the mothers and babies and their families who agreed to take part in these studies. This research could not have been performed without them. I will be forever grateful.
For full details of each study please refer to publications. See publication details in reference list.