Campanale, Nucera, Ojetti, Cesario, Di Rienzo, D’Angelo, Pecere, Barbaro, Gigante, De Pasquale, Rizzi, Cammarota, Schiavino, Franceschi, Gasbarrini 2014 — Nickel-free diet enhances Helicobacter pylori eradication rate
This Digestive Diseases and Sciences randomized pilot trial from the Gemelli Hospital (Rome) group tests whether a nickel-free diet added to standard triple therapy increases H. pylori eradication. The rationale: H. pylori requires the nickel-containing metalloenzymes urease and [NiFe]-hydrogenase to survive at low gastric pH; depleting dietary nickel could disable the pathogen’s acid-tolerance machinery and expose it to gastric acid plus amoxicillin. 52 first-diagnosis H. pylori patients were randomized 1:1 to standard LCA triple therapy (lansoprazole + clarithromycin + amoxicillin for 7 days) with a common diet, versus the same regimen plus a 30-day nickel-free diet starting 14 days before triple therapy. The intervention nearly doubled the eradication rate.
Key numbers
| Arm | Eradication rate | p |
|---|---|---|
| Standard LCA + common diet | 12/26 (46.2%) | reference |
| Standard LCA + nickel-free diet (NFD-LCA) | 22/26 (84.6%) | < 0.01 |
Side-effect rates did not differ between arms (9/52 reported mild therapy-related side effects).
Methods (brief)
Single-site pilot RCT, sex- and age-matched. The nickel-free diet was the standard low-Ni protocol used by the Gemelli allergology group; patients followed it for 30 days total, with triple therapy starting on day 15. Eradication confirmed by post-treatment H. pylori testing.
Implications
- Certification: Strong primary clinical-trial evidence that dietary nickel modulates H. pylori virulence machinery in vivo. The H. pylori urease and hydrogenase Ni-dependence is consistent with Maier and Benoit 2019 mechanism review; Campanale 2014 is the in-vivo human RCT confirming that nickel-availability manipulation translates to clinical pathogen-clearance outcomes. HMTc Ni-threshold rationale gains primary clinical support beyond the EFSA TDI exposure-assessment framing.
- Microbiome: Direct evidence for the nickel-microbial-pathogenesis mechanism translating to a human clinical endpoint.
- Courses: Standard reference for the dietary-nickel-and-pathogenesis bridge.