Probiotic BB-12 beats placebo for improving colic in babies: RCT

By Stephen Daniells contact

- Last updated on GMT

© reewungjune / Getty Images
© reewungjune / Getty Images

Related tags: BB-12, Probiotics, colic

Daily administration of the BB-12 probiotic may shorten crying times and improve daily sleeping time in babies with colic, says a new randomized, double-blind, placebo-controlled trial.

Three weeks of administration with Bifidobacterium animalis​ subsp. lactis​, BB-12 was also associated with significant improvements for parents and caregivers, with scores for their physical, emotional and social functioning all increasing, compared to placebo.

While other studies have reported BB-12 administration may improve colic, the study is reportedly the first to investigate a potential benefit of probiotic administration to colicky infants on their parents, as measured by Parent’s/caregiver’s Health Related Quality of Life (HRQoL) scores.

“The results of this study strongly support a clinically relevant benefit of the probiotic strain ​B. animalis subsp. ​lactis BB-12 on reducing crying and fussing in infants diagnosed with infant colic,” ​wrote researchers from China and Denmark’s Chr Hansen in the journal Beneficial Microbes.

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.

This has led to multiple studies using probiotics to impact measures of colic.

Study details

For the new study, the researchers recruited 192 full-term colicky infants younger than 3 months of age. The infants were randomly assigned to receive either 1 billion CFUs per day of BB-12 or placebo for three weeks.

The researchers reported that a significantly higher percentage of infants in the BB-12 group achieved a reduction in the daily crying/fussing time of at least 50% after three weeks, compared to placebo.

In addition, the BB-12 consuming babies also experienced significantly fewer crying episodes and increases in daily sleep duration, compared to the placebo-fed infants.

Immunity biomarkers in the babies’ feces were also analyzed, with the data showing that these immunity biomarkers increased in both groups, but a significantly greater increase was observed in the BB-12 group, “suggesting that the BB-12 strain may have an immunomodulatory action in the infant gut which could play a beneficial role in the context of infant colic”​, wrote the researchers.

“The study showed that the BB-12 strain, administered in a daily dose of 1×109 cfu for 21 days, was associated with treatment success (defined as the proportion of infants achieving a reduction in crying and fussing time of ≥50% from baseline), reduced crying duration and improved sleep duration,” ​they wrote. “These variables have all been considered clinically relevant in previous studies and meta-analyses.”

Source: Beneficial Microbes
Published online ahead of print, doi: 10.3920/BM2020.0233
“Efficacy of Bifidobacterium animalis subsp. lactis, BB-12 on infant colic - a randomised, double-blinded, placebo-controlled study”
Authors: K. Chen et al

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