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Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study.

Abstract

GOALS

To determine the efficacy of triple therapy supplemented with a specially designed fermented milk product containing specific probiotic Lactobacillus casei (L. casei) DN-114 001 strain on Helicobacter pylori eradication in children.

BACKGROUND

Lactobacillus species possess in vitro activity against H. pylori. There are no consistent data on the impact of eradication therapy supplemented with probiotics on H. pylori cure rates in childhood in vivo.

STUDY

Multicenter, prospective, randomized, double-blind controlled study. Eighty-six symptomatic H. pylori-positive children were randomized either to receive the control treatment of omeprazole, amoxicillin, and clarithromycin (OAC) for 7 days or the test treatment of omeprazole, amoxicillin, and clarithromycin for 7 days supplemented with fermented milk (Actimel) containing L. casei DN-114 001 (OAC-LC), for 14 days. H. pylori status was assessed at 4 weeks following therapy using two noninvasive tests.

RESULTS

Intention-to-treat (ITT) based eradication rates for the OAC-LC group were 84.6% (95% CI, 71.2%-95.5%), and 91.6% (95% CI, 76.9%-98.2%) by per-protocol (PP) analysis. Eradication in the OAC group was 57.5% (95% CI, 42.2%-72.3%) in the ITT set and 61.3% (95% CI, 44.4%-75.0%) in the PP group. Eradication success was higher in the OAC-LC group compared with the OAC group in both ITT (P=0.0045) and PP analysis (P=0.0019). Primary resistance for clarithromycin could be determined in 21.2%. Side effects were infrequent. Drug compliance was good throughout the study.

CONCLUSION

Supplementation with fermented milk, containing live special probiotic L. casei DN-114 001, confers an enhanced therapeutic benefit on H. pylori eradication in children with gastritis on triple therapy.

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  • Authors+Show Affiliations

    ,

    Department of Pediatrics, Division of Gastroenterology, Charles University Hospital, Pilsen, Czech Republic. sykorajo@fnplzen.cz

    , , , , , , , ,

    Source

    MeSH

    Antigens, Bacterial
    Child
    Cultured Milk Products
    Double-Blind Method
    Female
    Follow-Up Studies
    Gastric Mucosa
    Gastritis
    Gastroscopy
    Helicobacter Infections
    Helicobacter pylori
    Humans
    Lactobacillus casei
    Male
    Probiotics
    Prospective Studies
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    16082279

    Citation

    Sýkora, Josef, et al. "Effects of a Specially Designed Fermented Milk Product Containing Probiotic Lactobacillus Casei DN-114 001 and the Eradication of H. Pylori in Children: a Prospective Randomized Double-blind Study." Journal of Clinical Gastroenterology, vol. 39, no. 8, 2005, pp. 692-8.
    Sýkora J, Valecková K, Amlerová J, et al. Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study. J Clin Gastroenterol. 2005;39(8):692-8.
    Sýkora, J., Valecková, K., Amlerová, J., Siala, K., Dedek, P., Watkins, S., ... Schwarz, J. (2005). Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study. Journal of Clinical Gastroenterology, 39(8), pp. 692-8.
    Sýkora J, et al. Effects of a Specially Designed Fermented Milk Product Containing Probiotic Lactobacillus Casei DN-114 001 and the Eradication of H. Pylori in Children: a Prospective Randomized Double-blind Study. J Clin Gastroenterol. 2005;39(8):692-8. PubMed PMID: 16082279.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study. AU - Sýkora,Josef, AU - Valecková,Kristýna, AU - Amlerová,Jana, AU - Siala,Konrad, AU - Dedek,Petr, AU - Watkins,Stephen, AU - Varvarovská,Jana, AU - Stozický,Frantisek, AU - Pazdiora,Petr, AU - Schwarz,Jan, PY - 2005/8/6/pubmed PY - 2005/12/13/medline PY - 2005/8/6/entrez SP - 692 EP - 8 JF - Journal of clinical gastroenterology JO - J. Clin. Gastroenterol. VL - 39 IS - 8 N2 - GOALS: To determine the efficacy of triple therapy supplemented with a specially designed fermented milk product containing specific probiotic Lactobacillus casei (L. casei) DN-114 001 strain on Helicobacter pylori eradication in children. BACKGROUND: Lactobacillus species possess in vitro activity against H. pylori. There are no consistent data on the impact of eradication therapy supplemented with probiotics on H. pylori cure rates in childhood in vivo. STUDY: Multicenter, prospective, randomized, double-blind controlled study. Eighty-six symptomatic H. pylori-positive children were randomized either to receive the control treatment of omeprazole, amoxicillin, and clarithromycin (OAC) for 7 days or the test treatment of omeprazole, amoxicillin, and clarithromycin for 7 days supplemented with fermented milk (Actimel) containing L. casei DN-114 001 (OAC-LC), for 14 days. H. pylori status was assessed at 4 weeks following therapy using two noninvasive tests. RESULTS: Intention-to-treat (ITT) based eradication rates for the OAC-LC group were 84.6% (95% CI, 71.2%-95.5%), and 91.6% (95% CI, 76.9%-98.2%) by per-protocol (PP) analysis. Eradication in the OAC group was 57.5% (95% CI, 42.2%-72.3%) in the ITT set and 61.3% (95% CI, 44.4%-75.0%) in the PP group. Eradication success was higher in the OAC-LC group compared with the OAC group in both ITT (P=0.0045) and PP analysis (P=0.0019). Primary resistance for clarithromycin could be determined in 21.2%. Side effects were infrequent. Drug compliance was good throughout the study. CONCLUSION: Supplementation with fermented milk, containing live special probiotic L. casei DN-114 001, confers an enhanced therapeutic benefit on H. pylori eradication in children with gastritis on triple therapy. SN - 0192-0790 UR - https://www.unboundmedicine.com/medline/citation/16082279/full_citation L2 - http://Insights.ovid.com/pubmed?pmid=16082279 DB - PRIME DP - Unbound Medicine ER -