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Exploratory, Randomized, Double-blind, Placebo-controlled Study on the Effects of Bifidobacterium infantis Natren Life Start Strain Super Strain in Active Celiac Disease

  • 2013-02
  • Journal of Clinical Gastroenterology 47(2)
    • E. Smecuol
    • H. Hwang
    • E. Sugai
    • L. Corso
    • A. Cherñavsky
    • Franco P. Bellavite
    • Andrea González
    • F. Vodánovich
    • M. L. Moreno
    • H. Vázquez
    • G. Lozano
    • S. Niveloni
    • R. Mazure
    • J. Meddings
    • E. Mauriño
    • J. Bai

Abstract

Background/aims: The aim of this exploratory trial was to establish if the probiotic Bifidobacterium natren life start (NLS) strain strain may affect the clinical course and pathophysiological features of patients with untreated celiac disease (CD). Positive findings would be helpful in directing future studies.

Methods: Twenty-two adult patients having 2 positives CD-specific tests were enrolled. Patients were randomized to receive 2 capsules before meals for 3 weeks of either Bifidobacterium infantis natren life start strain super strain (Lifestart 2) (2×10(9) colony-forming units per capsule) (n = 12) or placebo (n = 10), whereas they also consumed at least 12 g of gluten/day. A biopsy at the end of the trial confirmed CD in all cases. The primary outcome was intestinal permeability changes. Secondary endpoints were changes in symptoms and the Gastrointestinal Symptom Rating Scale, and in immunologic indicators of inflammation.

Results: The abnormal baseline intestinal permeability was not significantly affected by either treatment. In contrast to patients on placebo, those randomized to B. infantis experienced a significant improvement in Gastrointestinal Symptom Rating Scale (P = 0.0035 for indigestion; P = 0.0483 for constipation; P = 0.0586 for reflux). Final/baseline IgA tTG and IgA DGP antibody concentration ratios were lower in the B. infantis arm (P = 0.055 for IgA tTG and P = 0.181 for IgA DGP). Final serum macrophage inflammatory protein-1β increased significantly (P < 0.04) only in patients receiving B. infantis. The administration of B. infantis was safe.

Conclusions: The study suggests that B. infantis may alleviate symptoms in untreated CD. The probiotic produced some immunologic changes but did not modify abnormal intestinal permeability. Further studies are necessary to confirm and/or expand these observations.

Trial registration: ClinicalTrials.gov NCT01257620.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium infantisImproved Gastrointestinal SymptomsBeneficial
Moderate
Bifidobacterium infantisIncreased Serum Macrophage Inflammatory Protein-1β LevelsNeutral
Small
Bifidobacterium infantis BI02Improved Gastrointestinal SymptomsBeneficial
Moderate
Bifidobacterium infantis BI02Increased Serum Macrophage Inflammatory Protein-1β LevelsNeutral
Small
Bifidobacterium infantis BI02No Change in Abnormal Intestinal PermeabilityNeutral
Small
Bifidobacterium infantis BI02Reduced IgA tTG Antibody ConcentrationsBeneficial
Small
Bifidobacterium infantis HA-116Improved Gastrointestinal SymptomsBeneficial
Moderate
Bifidobacterium infantis HA-116Increased Serum Macrophage Inflammatory Protein-1β LevelsNeutral
Small
Bifidobacterium infantis M-63Improved Gastrointestinal SymptomsBeneficial
Moderate
Bifidobacterium infantis M-63Increased Serum Macrophage Inflammatory Protein-1β LevelsNeutral
Small
Bifidobacterium infantis M-63No Change in Abnormal Intestinal PermeabilityNeutral
Small
Bifidobacterium infantis MAK22B04IImproved Gastrointestinal SymptomsBeneficial
Moderate
Bifidobacterium infantis MAK22B04IIncreased Serum Macrophage Inflammatory Protein-1β LevelsNeutral
Small
Bifidobacterium infantis MAK22B04IReduced IgA tTG Antibody Concentration RatiosBeneficial
Small
Bifidobacterium infantis SD-6720Improved Gastrointestinal SymptomsBeneficial
Moderate
Bifidobacterium infantis SD-6720Increased Serum Macrophage Inflammatory Protein-1β LevelsNeutral
Small
Bifidobacterium infantis SD-6720Reduced IgA tTG Antibody ConcentrationsBeneficial
Small
Bifidobacterium infantis VPro 53Improved Gastrointestinal SymptomsBeneficial
Moderate
Bifidobacterium infantis VPro 53Increased Serum Macrophage Inflammatory Protein-1β LevelsNeutral
Small
Bifidobacterium infantis VPro 53Reduced IgA tTG Antibody ConcentrationsBeneficial
Small
Bifidobacterium infantis VPro 53Safety Profile of Bifidobacterium InfantisBeneficial
Large

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