Published: Oct 7, 2013

Full Story:  http://www.medpagetoday.com/PrimaryCare/DietNutrition/42120

Overall, the evidence is insufficient to recommend the use of probiotics to prevent or treat colic in babies, especially in those who are formula fed, a systematic review and meta-analysis found.

Six of the 12 randomized trials that were reviewed suggested that probiotics reduced crying and six did not, according to a study by Valerie Sung, MPH, of the Murdoch Childrens Research Institute and Royal Children’s Hospital in Parkville, Australia, and colleagues.

Three of the five trials examining management of colic concluded that probiotics worked best in breastfed babies, including a study by Francesco Savino, MD, and colleagues, reported in the latest issue of JAMA Pediatrics.

Of the other two management trials, one suggested possible effectiveness in formula-fed babies with colic and one suggested ineffectiveness in breastfed babies with colic.

Only two of seven trials that examined the role of probiotics in preventing infant colic reported a decrease in crying time with probiotics compared with placebo. None of the remaining five trials found any difference between probiotic intervention and placebo.

“Larger and more rigorously designed randomized clinical trials are needed to examine the efficacy of the probiotic Lactobacillus reuteri in the management of breastfed and particularly formula-fed infants with colic and in the prevention of colic in healthy term infants,” researchers wrote.

Excessive infant crying or fussing for no apparent reason affects up to 20% of infants younger than 3 months, Sung and colleagues noted. It has a negative impact on the mother’s mental health, overall family quality of life, and “is the most common proximal risk factor for child abuse.”

A study by Ronald G. Barr, MDCM, of the University of British Columbia in Vancouver, and colleagues found that the crying curve for babies with shaken baby syndrome parallels that of the normal crying curve, but shaken baby syndrome cases tend to peak 4 to 6 weeks later than the peak for the crying curve. They suggested that the lag in hospitalization could be due to repeated episodes of shaking before hospitalization.

In addition, duration of crying beyond 3 months tends to negatively affect the child’s later years, including bouts of anxiety, hyperactivity, sleep disorders, and allergies.

A recent study by Luigi Titomanlio, MD, PhD, of Paris Diderot University in Paris, and colleagues found that those with colic as a baby were six times more likely to have migraine between the ages of 6 and 18.

But there are several problems that preclude definitive support for probiotics in babies with colic, Lana Gagin, MD, a pediatric specialist at Helen DeVos Children’s Hospital, Spectrum Health, in Grand Rapids, Mich., told MedPage Today.

“Several trials used lactobacillus but in different concentrations and different forms (such as capsules or liquid), and one study mixed lactobacillus with other probiotics,” Gagin said.

The best defense against colic is breastfeeding, Gagin said, “which is a wonderful source of probiotic activity.”

Sung and colleagues also pointed out problems with the studies including vastly different infant populations, different types and points of outcomes measures, and the potential for recall bias because of the use of crying diaries — especially nonvalidated diaries.

Furthermore, mothers in two management trials were on dairy-free diets, potentially confounding the true effect of probiotics. And two of the seven prevention trials with a low risk of bias did not examine crying as a primary outcome.

Sung and colleagues recently completed the Baby Biotics randomized trial in which they also sought to determine the underlying pathophysiological mechanisms in infant colic by examining infant fecal microbiota diversity, as well as infant fecal calprotectin levels andEscherichia coli load. Results are expected shortly.

Information about four other unpublished probiotics trials currently in progress can be found here, here, here, and here.

For the current systematic review and meta-analysis, researchers included 12 trials that randomized 1,825 infants 3 months or younger to probiotics versus placebo, or to standard treatment or no treatment at all.

“This review reflects current general consensus that, even though the use of a specific strain of probiotic (L reuteri) in breastfed term infants with colic is promising, there is still insufficient evidence to support the general use of probiotics in all infants with colic or to recommend its use in preventing colic,” they concluded.