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Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial
Nicole Y Fatheree1, Yuying Liu1, Christopher M Taylor2
1Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.
Insights
Probiotic Lactobacillus reuteri strain DSM 17938 is safe for infants with colic, even those with neutropenia. The study found no severe adverse events, suggesting a safe treatment option for infant colic.
Area of Science:
- Pediatrics
- Microbiology
- Immunology
Background:
- Infant colic is a common condition affecting newborns.
- Probiotics are increasingly explored for managing infant colic.
Purpose of the Study:
- To assess the safety of Lactobacillus reuteri strain DSM 17938 in infants with colic.
- To evaluate the effects of this probiotic on crying, fussing, and relevant biomarkers.
Main Methods:
- A controlled, double-blinded, phase 1 safety trial.
- 20 healthy breast-fed infants with colic were randomized to receive L reuteri strain DSM 17938 or placebo.
- Infants were followed for 134 days.
Main Results:
- L reuteri strain DSM 17938 showed no severe adverse events.
- No significant changes were observed in crying time, plasma bicarbonate, or inflammatory biomarkers.
- Fecal calprotectin decreased in both groups; colic resolution correlated with decreased specific gut bacteria.
Conclusions:
- Daily administration of L reuteri strain DSM 17938 is safe for infants with colic, including those with neutropenia.
- A significant placebo effect was observed, with many infants showing resolution within 3 weeks.
Objective:
To assess the safety of probiotic Lactobacillus reuteri strain Deutsche Sammlung von Mikroorganismen (DSM) 17938 with daily administration to healthy infants with colic and to determine the effect of L reuteri strain DSM 17938 on crying, fussing, inflammatory, immune, and microbiome variables.
Study Design:
We performed a controlled, double-blinded, phase 1 safety and tolerability trial in healthy breast-fed infants with colic, aged 3 weeks to 3 months, randomly assigned to L reuteri strain DSM 17938 (5 × 108 colony-forming units daily) or placebo for 42 days and followed for 134 days.
Results:
Of 117 screened infants, 20 were randomized to L reuteri strain DSM 17938 or placebo (sunflower oil) (in a 2:1 ratio) with 80% retention. Eleven of the 20 (55%) presented with low absolute neutrophil counts (<1500/mm3), which resolved in all subjects by day 176. L reuteri strain DSM 17938 produced no severe adverse events and did not significantly change crying time, plasma bicarbonate, or inflammatory biomarkers. Fecal calprotectin decreased rapidly in both groups. In the infants with dominant fecal gram negatives (Klebsiella, Proteus, and Veillonella), resolution of colic was associated with marked decreases in these organisms.
Conclusions:
Daily administration of L reuteri strain DSM 17938 appears to be safe in newborn infants with colic, including those with neutropenia, which frequently coexists. A placebo response of 66% suggests that many infants with colic will have resolution within 3 weeks.
Trial Registration:
ClinicalTrials.gov: NCT01849991.
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