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Infant behavioral state and stool microbiome in infants receiving Lactocaseibacillus rhamnosus GG in formula:
Robert J Shulman1,2,3,4, Maciej Chichlowski5, Fabiola Gutierrez Orozco5
1Baylor College of Medicine, One Baylor Plaza, Houston, TX, 77030, USA. rshulman@bcm.edu.
Insights
This pilot study found that partially hydrolyzed protein formula with added Lacticaseibacillus rhamnosus GG (LGG) successfully introduced the probiotic to infant gut microbiomes. While both formulas improved infant colic symptoms, the LGG-enhanced formula altered gut microbiome composition.
Area of Science:
- Infant nutrition
- Microbiome research
- Gastroenterology
Background:
- Infantile colic affects numerous infants, causing distress to both babies and parents.
- The gut microbiome plays a crucial role in infant health and development.
- Dietary interventions, including probiotics, are explored for managing infantile colic.
Purpose of the Study:
- To evaluate the impact of partially hydrolyzed protein formula (PHF) with or without Lacticaseibacillus rhamnosus GG (LGG) on infant behavioral state, stool microbiome, and calprotectin levels.
- To assess the tolerability and efficacy of PHF-LGG in infants with colic.
Main Methods:
- A single-center, double-blind, randomized controlled trial involving term infants diagnosed with colic.
- Infants received either PHF or PHF-LGG for three weeks.
- Infant behavior, stool microbiome composition (16S rRNA sequencing), LGG colonization (qPCR), and fecal calprotectin were assessed.
Main Results:
- Both formulas led to a decrease in crying/fussing and an increase in content behavior, with no significant group differences in colic resolution.
- Fecal calprotectin levels remained similar between groups.
- The PHF-LGG group showed increased LGG abundance and altered beta diversity compared to the PHF group, indicating successful probiotic introduction and microbiome modulation.
Conclusions:
- Partially hydrolyzed protein formula with added LGG is well-tolerated and effectively colonizes the infant gut microbiome.
- While both formulas improved colic symptoms, the addition of LGG induced significant changes in the gut microbiome composition.
- This study provides a foundation for further research into probiotic-supplemented formulas for infant colic.
Background:
Our aim was to evaluate infant behavioral state, stool microbiome profile and calprotectin in infants with infantile colic receiving a partially hydrolyzed protein formula with or without added Lacticaseibacillus (formerly Lactobacillus) rhamnosus GG (LGG).
Methods:
In this single-center, double-blind, controlled, parallel, prospective study, term infants (14-28 days of age) identified with colic (using modified Wessel's criteria: cried and/or fussed ≥ 3 h/day for ≥ 3 days/week, in a one-week period) were randomized to receive one of two formulas over a three-week feeding period: marketed partially hydrolyzed cow's milk-based infant formula (PHF, n = 35) or a similar formula with added LGG (PHF-LGG, n = 36). Parent-reported infant behavior was recorded at three time points (Study Days 2-4, 10-12, and 18-20). Duration (hours/day) of crying/fussing (averaged over each three-day period) was the primary outcome. Stool samples were collected at Baseline and Study End (Days 19-21) to determine stool LGG colonization (by qPCR) and microbial abundance (using 16S rRNA gene sequencing) and calprotectin (μg/g).
Results:
Duration of crying/fussing (mean ± SE) decreased and awake/content behavior increased over time with no significant group differences over the course of the study. There were no group differences in the percentage of infants who experienced colic by study end. Colic decreased by Study End vs Baseline in both groups. Change in fecal calprotectin also was similar between groups. Comparing Study End vs Baseline, LGG abundance was greater in the PHF-LGG group (P < 0.001) whereas alpha diversity was greater in the PHF group (P = 0.022). Beta diversity was significantly different between PHF and PHF-LGG at Study End (P = 0.05). By study end, relative abundance of L. rhamnosus was higher in the PHF-LGG vs PHF group and vs Baseline.
Conclusions:
In this pilot study of infants with colic, both study formulas were well tolerated. Crying/fussing decreased and awake/content behavior increased in both study groups over the course of the study. Study results demonstrate a successful introduction of the probiotic to the microbiome. The partially hydrolyzed protein formula with added LGG was associated with significant changes in the gut microbiome.
Trial Registration:
ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT02340143 . Registered 16/01/2015.
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