- 2025-02-06
- European journal of clinical nutrition 79(6)
- Ying Wang
- Harm Wopereis
- Alexia Kakourou
- Min Liu
- Jieling Wu
- Zailing Li
- Lili Zhang
- Meizhen Tan
- June Su Yin Low
- Mengjin Liu
- Guus Roeselers
- Jan Knol
- Wei Cai
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 112
- Population
- Healthy, fully formula-fed Chinese infants (54.8% born by C-section)
- Methods
- Randomized to receive a partially hydrolyzed whey-based protein formula with synbiotic mixture (scGOS/lcFOS and B. breve M-16V) or an intact protein formula with prebiotic scGOS/lcFOS, with breastfed reference group. Gut microbiota profiling by 16S rRNA sequencing at baseline, 17 weeks, and 12 months.
- Duration
- 17 weeks
- Funding
- Unclear
- Large Human Trial
- Rigorous Journal
Background
Birth by cesarean section (C-section) is associated with a delayed colonization of bifidobacteria and Bacteroidota species with potential negative health consequences. Previously, an infant formula with a synbiotic mixture of short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS [9:1]) and Bifidobacterium breve M-16V was found to restore the timely colonization of bifidobacteria in C-section born infants. In this study, we investigated the effect of this synbiotic mixture on gut microbiota development in C-section and vaginally-born infants participating in a growth equivalence trial (NCT03520764).Methods
Healthy, fully formula-fed Chinese infants were randomized to receive a partially hydrolyzed whey-based protein formula with the synbiotic mixture (n = 112), or an intact protein formula with scGOS/lcFOS (prebiotic, n = 112). Breastfed infants served as reference group (n = 60). Gut microbiota profiling by 16S rRNA gene sequencing of stools collected at baseline, 17 weeks (end of intervention) and 12 months of age was complemented with analysis of stool pH, short-chain fatty acids, lactic acids, and secretory IgA concentrations.Results
Both the prebiotic and the synbiotic formula supported a dominant and diverse infant-type bifidobacterial community, but with increased abundance of Bifidobacterium breve in the synbiotic group. In C-section born infants (54.8% of randomized) the synbiotic but not the prebiotic, enhanced the bifidobacterial species diversity and showed restoration of Parabacteroides at 17 weeks, and Bacteroides spp. at 12 months closer to that of the vaginally-born infants.Conclusion
The synbiotic was confirmed to support the restoration of important gut colonizers in infants born by C-section with effects observed even beyond the intervention period.