Human milk oligosaccharide supplementation in irritable bowel syndrome patients: A parallel, randomized, double-blind, placebo-controlled study

Neurogastroenterol Motil. 2020 Oct;32(10):e13920. doi: 10.1111/nmo.13920. Epub 2020 Jun 14.


Objectives: Human milk oligosaccharides safely and beneficially impact bifidobacteria abundance in healthy adults, while their effects in patients with irritable bowel syndrome (IBS) are unknown. Hence, we aimed to determine the dose of 4:1 mix of 2'-O-fucosyllactose and Lacto-N-neotetraose (2'FL/LNnT) that increases fecal bifidobacteria abundance without aggravating overall gastrointestinal symptoms in IBS patients in a randomized, double-blind, controlled study. Additionally, the impact of 2'FL/LNnT on the fecal bacterial profile was assessed.

Methods: Irritable bowel syndrome patients diagnosed according to the Rome IV criteria received placebo (glucose), or 5 g or 10 g 2'FL/LNnT for 4 weeks followed by a four-week follow-up period. Gastrointestinal Symptom Rating Scale-IBS was used to assess gastrointestinal symptom severity; fecal microbiota composition was evaluated by GA-map™ Dysbiosis Test.

Results: Of the included 60 patients, two (one placebo and one 10 g) discontinued prematurely. Fecal bifidobacteria abundance was increased at week 4, but not at week 8, in the 10 g group compared to the other groups. Severity of overall or individual gastrointestinal symptoms did not differ between the groups at week 4 or 8, and no symptom deterioration was seen in any of the groups. The 10 g dose influenced overall fecal microbiota composition, and responders-defined as bifidobacteria increase ≥50%-could be discriminated from non-responders based on fecal microbiota modulation.

Conclusions: The 10 g dose of 2'FL/LNnT induced an increase in the beneficial Bifidobacterium spp. without aggravating gastrointestinal symptoms in patients with IBS. This approach may be worthwhile to modulate gut microbiota of IBS patients toward a healthier profile.

Trial registration: NCT02875847.

Keywords: 2’-O-fucosyllactose; Bifidobacterium spp.; Lacto-N-neotetraose; human milk oligosaccharides; irritable bowel syndrome.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Gastrointestinal Microbiome / physiology*
  • Humans
  • Irritable Bowel Syndrome / diagnosis*
  • Irritable Bowel Syndrome / diet therapy*
  • Irritable Bowel Syndrome / physiopathology
  • Male
  • Middle Aged
  • Milk, Human*
  • Oligosaccharides / administration & dosage*
  • Young Adult


  • Oligosaccharides

Associated data