Findings from both meta-analyses support the view that the bacterial strain remains the only probiotic currently available that demonstrates a certain efficacy in tackling colic.
“With six positive randomised, double-blind and placebo-controlled clinical trials and nine meta-analyses, the proof of L. reuteri Protectis in infant colic is solid,” said Axel Sjöblad, managing director, BioGaia.
”Health care professionals can be reassured that they are suggesting an effective and safe treatment when recommending BioGaia Protectis drops to their patients.”
Cranky babies with colic
Colic refers to the condition that can affect 5% to 40% of infants. It is characterised by inconsolable and excessive crying that can be accompanied by bouts of fussiness and passing of gas.
These symptoms contribute to irritability and fussing lasting for at least three hours a day, for as long as three weeks.
Triggers for infantile colic remain elusive with theories proposed include overproduction of intestinal gas, forceful intestinal contraction and a lactase deficiency.
Theories explaining its onset have also been gut-centric with miscommunication between brain and intestine, hypersensitivity to cow's milk protein and changes in intestinal microbiota put forward.
Writing in the journal Medicine, the research team concluded that L. reuteri Protectis was considered the most effective treatment from a choice that included, drugs, herbs, acupuncture, massage, manipulation and reassurance/education.
The team, based at the UNITEC Technological University of Mexico placed specialised infant formulas (partially hydrolysed and whey-protein derivate), as the next best treatment.
Commenting on the systematic review that involved 32 trials and a networking meta-analysis approach, lead author Dr Pedro Gutiérrez-Castrellón, “supported the use of L. reuteri DSM 17938 as the most evidence-based significant intervention to reduce the duration of crying time in infant colic”.
Conclusions reached in Dr Gutiérrez-Castrellón’s study were mirrored by another meta-analysis that combined raw data from four double-blind trials.
All studies enrolled a total of 345 infants with colic that were administered with L. reuteri Protectis (manufactured by BioGaia) in the same dose (0.2 × 108 colony-forming units per drop, 5 drops orally per day), with control groups receiving the same placebo (maltodextrin in oil suspension).
The measured outcomes were of infant crying and/or fussing duration and treatment success at 21 days.
Led by Dr Valerie Sung, a consultant paediatrician and postdoctoral research fellow at Murdoch Children's Research Institute, the paper concluded that L. reuteri Protectis was effective and can be recommended for breastfed infants with colic.
However, the team—some of which disclosed personal fees from BioGaia outside the submitted work—acknowledged data was lacking for the strain’s efficacy in formula-fed infants.
The rapidly evolving universe of probiotics, prebiotics and the microbiome will be discussed in-depth at the upcoming IPA World Congress + Probiota 2018 in Barcelona on February 7-9.
From microbiome advances, to start-up game changers, market stats, crucial clinical science and regulatory knowledge, this is a congressional must-have.
Probiotics: The real deal?
Despite the showing of L. reuteri Protectis in these studies, the evidence of probiotic intervention in conditions like colic remain finally balanced.
Dr Sung was the lead author in another study that declared a lack of evidence to support its use in a sample of breastfed infants and formula fed infants with colic.
These findings differed from previous smaller trials of selected populations and the team, writing in the British Medical journal, “recommended caution in formulating recommendations regarding use of L reuteri DSM 17938 for reducing crying or fussing in breastfed, and particularly in formula fed, infants with colic.”
Published online ahead of print: doi: 10.1097/MD.0000000000009375
“Efficacy of Lactobacillus reuteri DSM 17938 for infantile colic: Systematic review with network meta-analysis.”
Authors: Pedro Gutiérrez-Castrellón et al.
Published online ahead of print: doi: 10.1542/peds.2017-1811
“Lactobacillus reuteri to treat infant colic: A meta -analysis"
Authors: Valerie Sung et al.