Human milk oligosaccharides (HMOs) produce similar changes in the gut microbiome of children with overweight as in infants and adults, suggesting that HMOs do not lead to digestive distress in children and do not cause safety concerns, according to study results published in the Journal of Pediatric Gastroenterology and Nutrition.
Among infants and adults, HMOs are safe and well-tolerated; however, their effects on intestinal microbiota, safety, and digestive tolerance in children are unclear. To address this knowledge gap, a team of researchers in Denmark conducted a randomized, double-blind, placebo-controlled study (ClinincalTrials.gov Identifier: NCT02786160) to determine whether HMOs can specifically modulate the intestinal microbiota in children. The investigators also aimed to assess the safety and digestive tolerance of HMOs in children with overweight.
A total of 75 children, aged 6 to 12 years, with overweight or obesity were randomly assigned to receive either 2’-fucosyllactose (2’FL), a combination of 2’FL and lacto-N-neotetraose (Mix), or glucose placebo, which were administered orally, once a day for 8 weeks.
The abundance of Bifidobacterium significantly increased from baseline to 4 weeks for patients in the 2’FL group (P <.001) and the Mix group (P =.003) but not for the placebo group. Additionally, only the 2’FL group continued to have significant increases from baseline to week 8 (P =.025).
Compared with the placebo cohort, the 2’FL cohort had a significant increase in the abundance of bifidobacteria after 4 weeks (P <.001) and 8 weeks (P =.010), while the Mix cohort exhibited increased bifidobacteria after 4 weeks (P =.071) and 8 weeks (P =.071). The bifidogenic effect seen in the 2 groups was driven by Bifidobacterium adolescentis.
“Biochemical markers indicated no safety concerns, and the products did not induce digestive tolerance issues as assessed by Gastrointestinal Symptoms Rating Scale and Bristol Stool Form Scale,” the authors noted.
This study was limited by its small sample size, potentially reducing its statistical power. Additionally, children included in the study cohort were also participating in a separate treatment program for obesity. Participation in this outside program may have affected the impact of this trial intervention.
“[T]he trial indicates that the HMOs are safe for use in children as the safety biomarkers in blood and feces did not suggest pathology, and the extended panel of blood markers did not give rise to concerns of the intervention,” the investigators concluded.
Fonvig CE, Amundsen ID, Vigsnæs et al. Human milk oligosaccharides modulate fecal microbiota and are safe for use in children with overweight: a randomized controlled trial. J Pediatr Gastroenterol Nutr. 2021;73(3):408-414. doi:10.1097/MPG.0000000000003205