Data published in the European Journal of Pediatrics indicated that synbiotic Bactecal D Liquid product not only reduced crying, gassiness, and other symptoms in infants with colic within a week, but also improved the quality of life (QoL) for their caregivers.
The results suggested that the product let to improvements in colic much earlier than it would naturally resolve, adding to evidence that the beneficial bacteria may be effective in addressing symptoms.
The supplement contained five different strains of bacteria and a small amount of fructo-oligosaccharides (FOS), defining it as a synbiotic where the bacteria and feeding substrate (prebiotic) are contained in one product.
“However, the content of FOS is small (20 mg/dosage), in comparison with the amount of human milk oligosaccharides in mother’s milk (~ 10 g/l),” wrote the researchers Vrije Universiteit Brussel.
“Therefore, the therapeutic effect is more likely to be the probiotic than the prebiotic effect.”
The impact of infant colic
Experts estimate that colic affects up to 28% of infants worldwide, with some suggesting prevalence to be as high as 40%.
Symptoms include persistent and inconsolable crying or screaming, going red in the face and making fists, and abdominal tension.
Although colic is a self-limiting condition that typically resolves itself between 3 and 4 months of age, it can have detrimental effects on caregivers, contributing to depression or stress.
Scientists don’t fully understand why infant colic (IC) develops but have proposed many contributing factors, including intolerance to cow’s milk in the diet of the breastfeeding caregiver, gut inflammation and hypermobility, and alterations in the microbiome.
Evidence for probiotics
Research suggests that the intestinal flora in colicky infants differs from those without symptoms.
“Dysbiosis has been shown to be present in IC, with a decreased presence of Bifidobacteria and an increased presence of the gas-producing proteobacteria,” the current study notes.
A 2019 Cochrane review concluded that there is no clear evidence that probiotics are more effective than placebo at preventing IC, but they do seem to reduce crying time.
Other studies suggest that particular strains of probiotics may be beneficial. However, evidence-based treatment recommendations do not currently exist, and healthcare experts do not routinely recommend them.
Study details
The randomized trial was conducted on 68 colicky infants aged between two and eight weeks old. They were divided into two groups, each taking either one or two daily doses of Bactecal D Liquid for 28 days.
The synbiotic supplement was formulated with L. rhamnosus PHA-113, L. acidolphilus PHA-121, B. infantis PHA-211, B. lactis PHA-222, and S. thermophilus PHA-311, fructooligosaccharides, vitamin D, and sunflower oil. The total dose from the five probiotic strains was 18 billion CFU.
The study’s primary outcome was the caregivers' QoL, differing from previous RCTs that assessed duration and episodes of crying, which can be objective measurements.
The results showed that QoL of the caregivers was significant from one week after the intervention for both groups, and crying episodes, overall crying time, gassiness, and “balling of fists” were significantly lower on day 28 compared to baseline.
Further analysis using breastfeeding as a reference revealed comparable QoL improvements in the mixed and exclusive formula-fed groups.
The researchers note the limitations of not having a placebo, which wasn’t possible due to ethical considerations of parents accepting the risk of unconsolable crying when there are many products on the market claiming efficacy. For this reason, they chose to compare dosages instead and found no difference in improvements between groups.
Source: European Journal of Pediatrics
Volume 184, Article number 27. doi: 10.1007/s00431-024-05860-5
“A synbiotic mixture for the management of infantile colic: A randomized trial”
Authors: H. Delcourt et al.