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Updated: Aug 9, 2025

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Published on: January 27, 2019
Early life gut microbiota profiles linked to synbiotic formula effects: a randomized clinical trial in European
Ilias Lagkouvardos1, Evangelia Intze2, Monika Schaubeck3
1Functional Microbiome Research Group, Institute of Medical Microbiology, RWTH University Hospital, Aachen, Germany; Institute of Marine Biology, Biotechnology and Aquaculture, Hellenic Centre for Marine Research, Heraklion, Greece.
Insights
A synbiotic formula containing Limosilactobacillus fermentum CECT5716 positively modulated infant gut microbiota, increasing beneficial bacteria and resembling breastfed infants. This early intervention impacts long-term infant health.
Area of Science:
- Microbiology
- Pediatrics
- Gastroenterology
Background:
- Infant gut microbial colonization is crucial for lifelong health.
- Early life interventions can positively influence this colonization.
- Investigating synbiotics is a promising strategy for modulating infant gut microbiota.
Purpose of the Study:
- To evaluate the effects of a synbiotic intervention formula (IF) on the fecal microbiome of 540 infants.
- To compare the synbiotic IF with a control formula (CF).
- To assess changes in microbiota composition, metabolites, and milieu parameters.
Main Methods:
- Randomized, controlled intervention study.
- 16S rRNA amplicon sequencing of fecal microbiota at 4, 12, and 24 months.
- Measurement of fecal metabolites (short-chain fatty acids) and milieu parameters (pH, IgA).
Main Results:
- Synbiotic IF altered microbiota profiles by 4 months, increasing Bifidobacterium and Lactobacillaceae, and decreasing Blautia and Ruminococcus gnavus.
- Fecal pH and butyrate concentrations were lower in the IF group.
- Infants receiving IF showed phylogenetic profiles closer to breastfed infants compared to CF.
Conclusions:
- Synbiotic intervention impacts early-life fecal microbiota and milieu parameters.
- The effects are dependent on infant microbiota profiles and show similarities to breastfed infants.
- Registered trial NCT02221687.
Background:
Microbial colonization of the gastrointestinal tract after birth is an essential event that influences infant health with life-long consequences. Therefore, it is important to investigate strategies to positively modulate colonization in early life.
Objectives:
This randomized, controlled intervention study included 540 infants to investigate the effects of a synbiotic intervention formula (IF) containing Limosilactobacillus fermentum CECT5716 and galacto-oligosaccharides on the fecal microbiome.
Methods:
The fecal microbiota from infants was analyzed by 16S rRNA amplicon sequencing at 4, 12, and 24 months of age. Metabolites (e.g., short-chain fatty acids) and other milieu parameters (e.g., pH, humidity, and IgA) were also measured in stool samples.
Results:
Microbiota profiles changed with age, with major differences in diversity and composition. Significant effects of the synbiotic IF compared with control formula (CF) were visible at month 4, including higher occurrence of Bifidobacterium spp. and Lactobacillaceae and lower occurrence of Blautia spp., as well as Ruminoccocus gnavus and relatives. This was accompanied by lower fecal pH and concentrations of butyrate. After de novo clustering at 4 months of age, overall phylogenetic profiles of the infants receiving IF were closer to reference profiles of those fed with human milk than infants fed CF. The changes owing to IF were associated with fecal microbiota states characterized by lower occurrence of Bacteroides compared with higher levels of Firmicutes (valid name Bacillota), Proteobacteria (valid name Pseudomonadota), and Bifidobacterium at 4 months of age. These microbiota states were linked to higher prevalence of infants born by Cesarean section.
Conclusions:
The synbiotic intervention influenced fecal microbiota and milieu parameters at an early age depending on the overall microbiota profiles of the infants, sharing a few similarities with breastfed infants. This trial was registered at clinicaltrials.gov as NCT02221687.
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