Daily consumption of BB-12 by the infants led to significant reductions in crying time, plus improvements in sleep duration and on stool frequency and consistency, according to findings published in Alimentary Pharmacology & Therapeutics.
“[O]ur study provides compelling evidences for the efficacy of Bifidobacterium animalis subsp. lactis BB‐12 in the treatment of IC [infant colic],” wrote scientists from the University of Naples Federico II.
“These evidences further support the important role of gut microbiota as target of intervention against IC. It is relevant to underline that this trial studied a specific well‐characterised probiotic strain, and that these findings cannot be extrapolated for other probiotic strains.”
Bifidobacterium (BB-12) has been used worldwide since 1985 as an ingredient in food and dietary supplements. It has been described in more than 315 scientific publications where more than 190 of these are from clinical studies.
The study used the commercial product Bifidolactis Infant by Italian probiotic player Sofar SpA. Sofar also funded the study. BB-12 is a trademark of Chr. Hansen.
1 in 4 infants worldwide suffers from colic
Colic is defined as severe pain in the abdomen caused by wind or obstruction in the intestines and suffered especially by babies. Characterized by excessive crying, grimacing, a red face, knees drawn up to the chest, clenched fists and excessive gas, the answer seems to lie in the gut. It’s one of the most common reasons parents seek medical advice during the first three months of their baby’s life.
Babies with colic have lower counts of good bacteria and increased concentrations of undesirable bacteria in their digestive tracts.
Ulla Holmboe Gondolf, senior scientific advisor at Chr. Hansen, commented: “The probiotic strain Bifidobacterium (BB-12) may ease colic by modifying the microbiota in infants with intestinal dysbiosis. The results indicate that the strain does this by increasing bifidobacterial abundance and by inhibiting the increase of harmful bacteria.”.
For their trial, the Naples-based researchers recruited 80 breast fed infants aged seven weeks or younger all of whom had been diagnosed with colic according to Rome III criteria. The infants were given a placebo, or 1 billion live bacteria per day of BB-12 oil drops for 28 days.
The results showed that, while crying decreased in both groups, the duration was reduced much more in the BB-12 group, while greater reductions in crying episodes were also observed for the probiotic-fed infants.
Overall, 80% of the infants supplemented with BB-12 met the trial primary endpoint criteria, showing a reduction in duration of crying by 50% or more.
“Supplementation with BB‐12 is effective in managing infant colic. The effect could derive from immune and non‐immune mechanisms associated with a modulation of gut microbiota structure and function,” concluded the researchers.
The first 1,000 days
Infant products are relatively well known, an increase in online consumer reviews of 477% from 2017 to 2019, closely followed by probiotics for pregnant and breastfeeding mothers, which increased by 114% (according to data from Lumina Intelligence).
Lumina Intelligence also notes that key areas of concern for consumers when purchasing probiotics for children include colic, constipation, and diarrhea reduction.
Culturelle is the most reviewed probiotic brand positioned for the ‘first 1,000 days’ based on data from 21 countries, added Lumina.
Specifically for colic, Lumina data shows that online engagement is on the rise, with the number of online reviews increasing 226% from 2017 to 2019 (see chart below).
Source: Alimentary Pharmacology & Therapeutics
Published online ahead of print, doi: 10.1111/apt.15561
“The therapeutic efficacy of Bifidobacterium animalis subsp. lactis (BB-12) in infant colic: a randomized, double blind, placebo-controlled trial”
Authors: R. Nocerino et al.