title: Exploratory, randomized, double-blind, placebo-controlled study on the effects of Bifidobacterium infantis natren life start strain super strain in active celiac disease.
abstract: OBJECTIVE
  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.
authors: Small Intestinal Section, Department of Medicine, Hospital de Clínicas José de San Martín, Universidad de Buenos Aires, Argentina.
authors: Edgardo
authors: E
authors: Smecuol
authors: Hui J
authors: HJ
authors: Hwang
authors: Emilia
authors: E
authors: Sugai
authors: Laura
authors: L
authors: Corso
authors: Alejandra C
authors: AC
authors: Cherñavsky
authors: Franco P
authors: FP
authors: Bellavite
authors: Andrea
authors: A
authors: González
authors: Florencia
authors: F
authors: Vodánovich
authors: María L
authors: ML
authors: Moreno
authors: Horacio
authors: H
authors: Vázquez
authors: Graciela
authors: G
authors: Lozano
authors: Sonia
authors: S
authors: Niveloni
authors: Roberto
authors: R
authors: Mazure
authors: Jon
authors: J
authors: Meddings
authors: Eduardo
authors: E
authors: Mauriño
authors: Julio C
authors: JC
authors: Bai
mesh_terms: D000328:Adult; D000368:Aged; D001118:Argentina; D001323:Autoantibodies / Q000097:blood; D001644:Bifidobacterium / Q000254:growth & development*; D015415:Biomarkers / Q000097:blood; D001706:Biopsy; D002446:Celiac Disease / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000276:immunology / Q000382:microbiology / Q000628:therapy*; D002478:Cells, Cultured; D054407:Chemokine CCL4 / Q000097:blood; D003131:Combined Modality Therapy; D055050:Diet, Gluten-Free; D004311:Double-Blind Method; D005260:Female; D019204:GTP-Binding Proteins; D005903:Gliadin / Q000276:immunology; D006801:Humans; D007408:Intestinal Absorption; D007413:Intestinal Mucosa / Q000378:metabolism; D007422:Intestines / Q000276:immunology / Q000382:microbiology* / Q000473:pathology; D007792:Lactulose / Q000652:urine; D008297:Male; D008353:Mannitol / Q000652:urine; D008875:Middle Aged; D010446:Peptide Fragments / Q000276:immunology; D010539:Permeability; D019936:Probiotics / Q000627:therapeutic use*; D000091345:Protein Glutamine gamma Glutamyltransferase 2; D011795:Surveys and Questionnaires; D013997:Time Factors; D011503:Transglutaminases / Q000276:immunology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001323:Autoantibodies; D015415:Biomarkers; C066507:CCL4 protein, human; D054407:Chemokine CCL4; D010446:Peptide Fragments; D008353:Mannitol; D007792:Lactulose; D005903:Gliadin; D000091345:Protein Glutamine gamma Glutamyltransferase 2; D011503:Transglutaminases; D019204:GTP-Binding Proteins