Probiotic supplements superior to reference drug for colic relief: Study

Daily consumption of B. breve​ CECT7263 by the infants led to significant reductions in crying time during the first week of the study, and parents of these infants reported a more positive mood after 28 days of probiotic supplementation, according to findings published in Beneficial Microbes​.

In addition, improvements in the duration of crying from baseline levels in the CECT7263 group were superior to those recorded for infants administered the reference prescribed drug, simethicone, reported researchers led by Jose Maldonado-Lobón and Ruth Blanco-Rojo from Spain’s Biosearch Life.

“The breastmilk-isolated probiotic strain B. breve CECT7263 seems to have an earlier and more robust effect on infant colic than simethicone, since the consumption of B. breve CECT7263 reduced the daily time of crying in infants diagnosed with infantile colic from the first week of the intervention and at a higher percentage,”​ wrote the researchers.

“These results were observed in infants feeding with breastmilk or infant formula and were accompanied by the observation of better infants’ night sleep and an improvement in the parents’ mood. ​

“All of this, together with the fact that the study subjects did not suffer from adverse effects and that the probiotic was well tolerated, supports the role of B. breve CECT7263 as a safe and effective treatment option for infant colic, presenting an earlier and more robust effect than the reference prescribed drug for infantile colic, simethicone,” ​they added.

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.

Study details​

The new study was a multi-center, randomized, open-label, parallel, controlled trial including 150 infants who were diagnosed with colic according to the Rome III criteria. The infants were randomly assigned to one of three groups: One group received 80 mg/day of simethicone; one group received 200 million CFU per day of B. breve​ CECT7263; and the final group received 100 million CFU per day of B. breve​ CECT7263 combined with 100 million CFU per day of L. fermentum​ CECT5716.

The researchers reported that, while all the interventions produced significant decreases in daily crying time after 28 days, the decreases in crying for infants receiving B. breve​ CECT7263 reached statistical significance from the first week in both infants feeding with breastmilk and formula. The superiority of CECT7263 over simethicone was maintained for every week of the study.

The researchers noted that the combination of the two strains also reduced crying time, and this exceeded simethicone at some points. However, the efficacy of the probiotic combination was lower than when CECT7263 alone and may be related to the dose of CECT7263 used in the combination product.

“Although only few studies have evaluated the dose response effect of probiotics, some authors have found a relationship between the administered dose and the observed effect,” ​they added.

Infants in the B. breve​ CECT7263 group also had better night sleep, with their parents reporting a more positive mood at the end of the intervention.

“In conclusion, the breastmilk-isolated probiotic strain ​B. breve CECT7263 is a safe and effective treatment for infantile colic, presenting an earlier and more robust effect than the reference prescribed drug, simethicone,” ​they wrote.

Source: Beneficial Microbes​
Volume 12, Issue 1, Pages 55–67, doi: 10.3920/BM2020.0105​
“Efficacy of ​Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial”​
Authors: J.A. Maldonado-Lobón, et al.