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Effect of Bifidobacterium infantis NLS super strain in symptomatic coeliac disease patients on long-term gluten-free diet - an exploratory study.

  • 2020-10-12
  • Beneficial Microbes 11(6)
    • E. Smecuol
    • Marco Constante
    • M. P. Temprano
    • A. F. Costa
    • M. L. Moreno
    • M. Pinto-Sanchez
    • H. Vázquez
    • J. Stefanolo
    • Andrea F. Gonzalez
    • C. D’Adamo
    • S. Niveloni
    • E. Mauriño
    • Elena F Verdu
    • Julio C. Bai

Abstract

Bifidobacterium infantis NLS super strain (B. infantis NLS-SS) was previously shown to alleviate gastrointestinal symptoms in newly diagnosed coeliac disease (CD) patients consuming gluten. A high proportion of patients following a gluten-free diet experiences symptoms despite dietary compliance. The role of B. infantis in persistently symptomatic CD patients has not been explored. The aim of the study was to evaluate the effect of B. infantis NLS-SS on persistent gastrointestinal symptoms in patients with CD following a long-term GFD. We conducted a randomised, cross-over, double-blind, placebo-controlled trial in symptomatic adult CD patients on a GFD for at least two years. After one-week run-in, patients were randomised to B. infantis NLS-SS or placebo for 3 weeks with cross-over after a 2-week wash-out period. We estimated changes (Δ) in celiac symptom index (CSI) before and after treatment. Stool samples were collected for faecal microbiota analysis (16S rRNA sequencing). Gluten immunogenic peptide (GIP) excretion in stool and urine samples was measured at each study period. Eighteen patients were enrolled; six patients were excluded due violations in protocol. For patients with the highest clinical burden, CD symptoms were lower in probiotic than in placebo treatment (P=0.046). B. infantis and placebo treated groups had different microbiota profiles as assessed by beta diversity clustering. In probiotic treated groups, we observed an increase in abundance of B. infantis. Treatment with B. infantis was associated with decreased abundance of Ruminococcus sp. and Bifidobacterium adolescentis. GIP excretion in stools and urine was similar at each treatment period. There were no differences in adverse effects between the two groups. B. infantis NLS-SS improves specific CD symptoms in a subset of highly symptomatic treated patients (GFD). This is associated with a shift in stool microbiota profile. Larger studies are needed to confirm these findings. ClinicalTrials.gov: NCT03271138.

Keywords: coeliac disease; faecal microbiota; gluten-free diet; probiotics.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
BifidobacteriumAltered Gut MicrobiotaNeutral
Moderate
BifidobacteriumReduced Gastrointestinal SymptomsBeneficial
Small
Bifidobacterium infantisAltered Gut MicrobiotaNeutral
Moderate
Bifidobacterium infantisImproved Gastrointestinal SymptomsBeneficial
Small
Bifidobacterium infantis BI02Altered Gut MicrobiotaNeutral
Moderate
Bifidobacterium infantis BI02Reduced Gastrointestinal SymptomsBeneficial
Small
Bifidobacterium infantis HA-116Altered Stool Microbiota ProfileNeutral
Moderate
Bifidobacterium infantis HA-116Improved Overall Gastrointestinal SymptomsBeneficial
Moderate
Bifidobacterium infantis M-63Altered Gut MicrobiotaNeutral
Moderate
Bifidobacterium infantis M-63Reduced Gastrointestinal SymptomsBeneficial
Small
Bifidobacterium infantis MAK22B04IAltered Gut MicrobiotaNeutral
Moderate
Bifidobacterium infantis MAK22B04IImproved Coeliac Disease SymptomsBeneficial
Moderate
Bifidobacterium infantis SD-6720Altered Microbial ProfileNeutral
Moderate
Bifidobacterium infantis SD-6720No Increase in Adverse EffectsNeutral
Small
Bifidobacterium infantis SD-6720Reduced Gastrointestinal SymptomsBeneficial
Small
Bifidobacterium infantis VPro 53Altered Faecal Microbiota ProfileNeutral
Moderate
Bifidobacterium infantis VPro 53Reduced Gastrointestinal SymptomsBeneficial
Small

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