Efficacy of IgY on Helicobacter pylori eradication and improvement of clinical symptoms: a randomized double-blind clinical trial

Abstract Background Helicobacter pylori infection is a global health concern associated with gastritis, peptic ulcer disease, and gastric cancer. With increasing antibiotic resistance, egg yolk immunoglobulin (IgY) has emerged as a promising candidate owing to its stability and pathogen-neutralizing effects. This clinical trial evaluated the efficacy of IgY-enriched egg yolk powder (anti-H. pylori IgY) in eliminating the bacterium and improving clinical symptoms as an adjunctive. Methods In this randomized, double-blind trial, 60 patients with confirmed H. pylori infection received a 14-day standard therapy regimen (omeprazole, amoxicillin, clarithromycin) supplemented with IgY-enriched egg yolk powder (intervention) or plain egg yolk powder (control). The primary outcome was bacterial eradication, assessed by the 14C-urea breath test (14C-UBT) performed 4 weeks after completion of therapy (i.e. 6 weeks from baseline). Secondary outcomes included symptom improvement (abdominal pain, nausea, bloating, and anorexia) measured using the Gastrointestinal Symptom Rating Scale (GSRS), via telephone interviews conducted three times weekly for 3 weeks. Data were analyzed using analysis of variance (ANOVA) and t-tests (SPSS v24). Results Baseline demographic characteristics were homogeneous. The median UBT value in the intervention group decreased from 77 to 11, whereas that of the control group remained unchanged (median = 55). Bacterial eradication was achieved in 33.3% of IgY recipients versus 13.3% of controls (difference, 20%; p = 0.241). IgY was well tolerated, with no treatment-related adverse events observed in the intervention group. Conclusion Clinical symptoms showed trends toward faster improvement, but these did not reach statistical significance. IgY may be a promising safe adjunct for the treatment of H. pylori infection. Clinical Trial Registration NCT06973889.