Bovine antibody-based oral immunotherapy for reduction of intragastric Helicobacter pylori
colonization: A randomized placebo-controlled clinical trial
C.M. den Hoed1, A.C. de Vries1, P.B.F. Mensink1, C.M. Dierikx1, N. de Groot2, L. Capelle1, H. van
Dekken3, E.J. Kuipers1, 4
C.M. den Hoed1, A.C. de Vries1, P.B.F. Mensink1, C.M. Dierikx1, N. de Groot2, L. Capelle1, H. van
Dekken3, E.J. Kuipers1, 4
For treatment of H. pylori (Hp) infections antibiotic-based regimens are mostly used. However, antibioticbased eradication fails in 15-40% of patients, due to antimicrobial resistance and poor patient compliance.
Effective prevention and eradication of Hp by passive immunisation with orally administered bovine
antibodies has been demonstrated in animal studies and may serve as an alternative therapy in humans.
The aim of this study was to study efficacy and safety of orally administered antibodies for reduction of
intragastric bacterial load and eradication of Hp in humans.
Polyclonal antibodies (sIgA) were raised in milk of dairy cows by nasal and supra-mammary lymph node
immunisations with a mix of clinical Hp isolates during lactation. The milk was processed into a whey
protein concentrate (WPC). A prospective, double-blind, placebo-controlled randomized clinical trial was
designed. Hp-infected subjects were randomized into a WPC-treated or placebo-treated group. Study
medication was continued for 28 days; subjects were followed up for 56 days. Efficacy of treatment was
evaluated as reduction in intragastric Hp colonization density, determined by urea breath test (UBT) and
histology. A blinded pathologist assessed biopsies according to the updated Sydney classification system.
Safety was evaluated with blood tests and quality of life questionnaires. All outcome measures were
evaluated on day 0 and day 29; on day 56 UBT, blood tests and quality of life questionnaires were repeated.
In total, 30 subjects were included; 27 completed the protocol, and the remainder either discontinued study
medication within 2 weeks or was lost to follow-up. Within 27 evaluable subjects, there was no significant
difference in UBT decrease between the WPC- and the placebo-group (mean decrease ± SEM 0.9 ± 4.3 vs.
3.0 ± 5.0, p=0.75). Hp density and polymorphonuclear neutrophil activity in antrum and corpus were not
significantly reduced after treatment in both groups (all p>0.05). In one subject, Hp eradication was
achieved after concomitant use of the WPC-product and a 1 day metronidazole course. No serious adverse
effects occurred after treatment with the WPC-product.
Bovine antibody-based oral immunotherapy appears safe, but does not significantly reduce intragastric Hp
density in humans. However, further studies are needed to determine whether WPC treatment has
additional value to conventional antibiotic treatment for Hp.