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.
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
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.
Sýkora
Josef
J
Department of Pediatrics, Division of Gastroenterology, Charles University Hospital, Pilsen, Czech Republic. sykorajo@fnplzen.cz
Valecková
Kristýna
K
Amlerová
Jana
J
Siala
Konrad
K
Dedek
Petr
P
Watkins
Stephen
S
Varvarovská
Jana
J
Stozický
Frantisek
F
Pazdiora
Petr
P
Schwarz
Jan
J
D000942:Antigens, Bacterial / Q000032:analysis; D002648:Child; D043302:Cultured Milk Products; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007780:Lacticaseibacillus casei; D008297:Male; D019936:Probiotics / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
D000942:Antigens, Bacterial