Baby colic – treated with an ancient dietary remedy and now backed by science

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.

1. When It All Began

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%.

2. A Pilot Study

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. 

3. A Controlled Study

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:

• Exclusively breastfeeding mothers whose babies met the Wessel criteria for infantile colic were recruited 
  
• Babies needed to be ≤ 9 weeks of age, born full-term, have no underlying medical conditions, not on any medication and exclusively breastfed (no other fluids)
  
• Mothers had to be 18-45 years of age, with no underlying medical conditions, not requiring mediation and have no known food allergies
  

Two 10-day maternal study diets were provided – each participant was randomly assigned to one diet first then crossed-over to the alternate diet

1. A Low FODMAP diet for 10 days
2. A typical Australian diet for 10 days

• Breast milk samples and baby poo samples were collected at various time points. Before the dietary interventions began (at baseline) and at the end of each of the two study-diets.
  
• The mother’s mental well-being status was assessed before the dietary intervention began and at the end of each of the two study-diets
  
• A validated diary (Barr Diary) was used to collect infant behaviours on every single day of the study (crying, fussing, sleeping, feeding and awake and content times and number of episodes)
  
• Food diaries and collection of food containers were used to measure compliance to the diets
  
• A control group was recruited without colic and observed in the same manner as the colic group, but breastfeeding mothers stayed on their normal diet. No food was provided.
  

Results:

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:

• Dietary compliance was met >98% of the time and only one mother was less compliant (70% of the time)
  
• Crying-fussing times associated with infantile colic reduced by an average of 35% (>25%deemed clinically significant) in the low FODMAP diet and 8% in the typical Australian diet (not clinically significant)
  
• Crying-fussing times between colic and non-colic groups were significantly different – 4.5 hours per day in the colic group compared to 1.5 hours per day in the non-colic group
  
• Baby awake and content times significantly increased on the low FODMAP diet greater than typical Australian diet
  
• Baby sleeping times remained stable
  
• Lactose remained stable for all groups throughout the study and regardless of diet
  
• Calprotectin measures (a marker of inflammation) in the baby poo samples decreased over time but did not change due to diet. This was found in both colic and non-colic groups
  
• Maternal stress and anxiety scores were reduced with the typical Australian diet but remained stable on the low FODMAP diet
  
• Maternal stress, anxiety and depression scores remained unchanged in the group without colic but were significantly lower than the colic group
  

In summary:

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.  

4. Next steps

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. 

Please read Part 1 for the first part of this blog

References:

1. Iacovou, M., Mulcahy, E. C., Truby, H., Barrett, J. S., Gibson, P. R., & Muir, J. G. (2017). Reducing the maternal dietary intake of indigestible and slowly absorbed short-chain carbohydrates is associated with improved infantile colic: a proof-of-concept study. Journal of Human Nutrition and Dietetics, June 10, DOI: 10.1111/jhn.12488. doi:doi: 10.1111/jhn.12488
2. Iacovou, M., Craig, S. S., Yelland, G. W., Barrett, J. S., Gibson, P. R., & Muir, J. G. (2018). Randomised clinical trial: reducing the intake of dietary FODMAPs of breastfeeding mothers is associated with a greater improvement of the symptoms of infantile colic than for a typical diet. Aliment Pharmacol Ther, October 11, DOI: 10.1111/apt.15007. doi:DOI: 10.1111/apt.15007
3. Iacovou, M., Ralston, R. A., Muir, J., Walker, K. Z., & Truby, H. (2012). Dietary management of infantile colic: A systematic review. Maternal and Child Health Journal, 16(6), 1319-1331. doi:10.1007/s10995-011-0842-5
4. Hill DJ, Roy N, Heine RG, et al. Effect of a low‐allergen maternal diet on colic among breastfed infants: a randomized, controlled trial. Pediatrics. 2005;116:e709‐e715.
5. Barr, R. G., Trent, R. B., & Cross, J. (2006). Age-related incidence curve of hospitalized Shaken Baby Syndrome cases: Convergent evidence for crying as a trigger to shaking. Child Abuse and Neglect, 30(1), 7-16. doi:10.1016/j.chiabu.2005.06.009