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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

Smecuol, Edgardo MD*,†; Hwang, Hui J. MD*; Sugai, Emilia MD*; Corso, Laura MD; Cherñavsky, Alejandra C. MD§; Bellavite, Franco P. MD*; González, Andrea MD; Vodánovich, Florencia MD§; Moreno, María L. MD*; Vázquez, Horacio MD*,†; Lozano, Graciela MD*; Niveloni, Sonia MD*,†; Mazure, Roberto MD*; Meddings, Jon MD; Mauriño, Eduardo MD*; Bai, Julio C. MD*,†,#

Journal of Clinical Gastroenterology: February 2013 - Volume 47 - Issue 2 - p 139–147
doi: 10.1097/MCG.0b013e31827759ac
ALIMENTARY TRACT: Original Articles
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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) (2×109 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.

Supplemental Digital Content is available in the text.

*Small Intestinal Section, Department of Medicine

Department of Alimentation, Hospital de Gastroenterología “Dr. C. Bonorino Udaondo”

§Department of Immunogenetics, Hospital de Clínicas “José de San Martín”, Universidad de Buenos Aires

Consejo de Investigación en Salud, Ministerio de Salud, Ciudad de Buenos Aires

#Department of Gastroenterology, Universidad del Salvador, Buenos Aires, Argentina

Gastrointestinal Research Group, University of Calgary, Calgary, AB, Canada

Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website, www.jcge.com.

Funded, in part, by Consejo de Investigación en Salud; Ministerio de Salud; Gobierno de la Ciudad de Buenos Aires; The National Institute of Probiotics, Westlake Village, CA; and Research Grant from the Research Committee of the Sociedad Argentina de Gastroenterología.

This is an investigator-performed study and Natren Inc. had no direct or indirect involvement in the design of the study, data collection, nor preparation or submission of the manuscript. Inova Diagnostic Inc. generously provided assays. Opinions and conclusions of the study were exclusively produced by the authors. None of the authors have a personal conflict of interest with the manufacturer.

Authors contribution: E.S.: Study design and study execution, analysis of data, revision of manuscript. H.J.H.: Study execution, analysis of data. E.S.: Laboratory procedures. L.C.: Dietary supervisión for patients. A.C.: Immunological tests and revisión of manuscript. F.P.B., M.L.M., S.N., R.M.: Study execution. A.G.: Study design and dietary supervisión for patients. F.V.: Immunological tests. H.V.: Study design and analysis of data. G.L.: Pathology analysis. J.M.: Permeability tests and revision of manuscript. E.M.: Study design and critical revision of manuscript. J.C.B.: Study design, supervision, analysis of data, writing of manuscript.

Reprints: Julio C. Bai, MD, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital, Av. Caseros 2061, Buenos Aires 1264, Argentina (e-mail: jbai@intramed.net).

Received August 12, 2012

Accepted October 3, 2012

© 2013 Lippincott Williams & Wilkins, Inc.