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Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial
Valerie Sung1, Harriet Hiscock, Mimi L K Tang
1Royal Children's Hospital, Parkville, Victoria, Australia.
Insights
Probiotic Lactobacillus reuteri DSM 17938 did not reduce crying or fussing in infants with colic. This study found no benefit for colic treatment in a broad community sample, differing from smaller trials.
Area of Science:
- Pediatrics
- Microbiology
- Gastroenterology
Background:
- Infant colic is a common condition characterized by excessive crying and fussing.
- Probiotics, particularly Lactobacillus reuteri DSM 17938, have shown potential in smaller trials for managing infant colic.
Purpose of the Study:
- To evaluate the efficacy of Lactobacillus reuteri DSM 17938 in reducing crying and fussing in a broad community-based sample of infants with colic.
- To assess the impact of the probiotic on infant sleep, maternal mental health, and family functioning.
Main Methods:
- A double-blind, placebo-controlled randomized trial was conducted with 167 infants under 3 months old meeting Wessel's criteria for colic.
- Participants received daily oral Lactobacillus reuteri DSM 17938 (1 × 10^8 CFU) or a placebo for one month.
- Primary outcome was the daily duration of crying or fussing at one month; secondary outcomes included sleep duration, maternal mental health, and infant functioning.
Main Results:
- No significant reduction in crying or fussing was observed in the probiotic group compared to placebo at one month (49 minutes more crying/fussing in probiotic group, P=0.02).
- The difference in crying/fussing was primarily driven by increased fussing, particularly in formula-fed infants.
- All secondary outcomes, including sleep duration, maternal mental health, and infant functioning, were similar between the groups. No adverse events were reported.
Conclusions:
- Lactobacillus reuteri DSM 17938 did not demonstrate a benefit for treating colic in a broad community sample of breastfed and formula-fed infants.
- These findings contrast with previous smaller studies and do not support a general recommendation for using this probiotic for infant colic.
Objective:
To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
Design:
Double blind, placebo controlled randomised trial.
Setting:
Community based sample (primary and secondary level care centres) in Melbourne, Australia.
Participants:
167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel's criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
Interventions:
Oral daily L reuteri (1 × 10(8) colony forming units) versus placebo for one month.
Main Outcomes Measures:
The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
Results:
Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
Conclusions:
L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
Trial Registration:
Current Controlled Trials ISRCTN95287767.
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