Digestive Diseases and Sciences
Cure8 research brief
Why This Matters
Many patients and clinicians seek safer, non-immunosuppressive options for Crohn’s disease. This randomized trial found LDN did not induce endoscopic or clinical remission, though it may reduce fatigue—information that helps set realistic expectations and guide future research.
Who Should Pay Attention
Adults with Crohn’s disease, clinicians managing IBD, and researchers studying repurposed or symptom-directed therapies.
Study Snapshot
Story typeResearch paper
Evidence typeResearch paper
Source depthMetadata only
What To Know
This randomized, placebo-controlled multicenter trial tested low-dose naltrexone (LDN) 4.5 mg daily versus placebo for 12 weeks in adults with mild-to-moderate Crohn’s disease confirmed by endoscopy. The trial was stopped early for futility. LDN did not improve endoscopic or overall clinical remission compared with placebo.
No serious adverse events were reported. A secondary finding was a small improvement in patient-reported fatigue (FACIT-Fatigue) with LDN versus placebo, but other patient-reported outcomes showed no consistent benefit.
Because the study was terminated early and enrolled only 41 patients, it lacked power to detect modest effects on endoscopic healing or clinical remission.
If you’re considering LDN because of concerns about conventional immunosuppression, note that this trial did not support LDN as an effective induction therapy for endoscopic or clinical remission in Crohn’s disease; any potential role may be limited to symptom domains like fatigue and requires further study.
Keep In Mind
Premature trial termination and small sample size reduce confidence in both the negative primary outcome and the secondary fatigue finding. The fatigue result is hypothesis-generating and not proof of clinical benefit.
Source Details
Review the original publication for the complete reporting, methods, and context.
Research paper
Evidence type derived from source or registry metadata.
PublicationDigestive Diseases and Sciences
PublisherSpringer Science and Business Media LLC
AuthorsN. van de Pol, E. Paulides, F. H. J. Wolfhagen +6 more
Study typeJournal Article
Indexed viaCrossref
Source typeResearch paper
PublishedSep 6, 2026, 12:00 AM
Content availableMetadata only
Funding disclosed by the source: ZonMw, award 848082001
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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