Overview
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.
Wiki pages updated on ingest
Update history
The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.
| Commit | Date | Change | Description |
|---|---|---|---|
| a8052bb | 2026-08-09 | major | 1 source added; 6 sections added; narrative text revised |