ClinicalTrials.gov
Cure8 trial brief
Oral N-acetylglucosamine in Crohn's Disease
Research and clinical trials
Genetics and genomics
Microbiome
Phase 2 clinical trial
Adult patients
Patients On Biologics
Clinicians
Researchers
Why This Matters
This trial tests a safe, non-drug supplement (GlcNAc) as a precision-medicine approach for Crohn's disease based on a genetic variant that affects glycosylation. If successful, it could offer a new, well-tolerated strategy to target a biological pathway not addressed by current medications.
Who Should Pay Attention
Adults with Crohn's disease, patients interested in genetics-informed treatments, clinicians following emerging IBD trials, and researchers studying glycosylation, microbiome, or personalized therapies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 2
Enrollment40 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a Phase 2, randomized, double-blind, placebo-controlled crossover trial testing oral N-acetylglucosamine (GlcNAc) in adults with Crohn's disease.
About 40 participants will be enrolled in two genotype-stratified cohorts (ZIP8 391‑Thr carriers and non-carriers) to evaluate safety, tolerability, and proof-of-concept biological effects over an 18-week study period.
Participants will mix GlcNAc powder in water and take it three times daily, with serial collection of blood, stool, and saliva samples and periodic clinic visits; intestinal ultrasound will be done when possible. ZIP8 genotype will be assessed at enrollment and participants may choose to learn their result.
The study tests a genetics-informed hypothesis: ZIP8 391‑Thr reduces manganese and impairs N‑glycosylation, and raising UDP‑GlcNAc levels with oral GlcNAc may restore N‑glycan branching and improve markers of gut biology.
Prior animal data and small human studies motivated this trial, which focuses on safety/tolerability and mechanistic signals rather than definitive efficacy. This summary is based on the clinicaltrials.gov record for NCT07225998 and describes the registered trial design and planned procedures.
Keep In Mind
This is a Phase 2, proof-of-concept study focused on safety, tolerability, and biological signals; it is NOT a completed efficacy trial. The record is a trial registry entry (clinicaltrials.gov) from Johns Hopkins University; results are not reported here. GlcNAc is being tested as a supplement because direct manganese supplementation carries neurological risks.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorJohns Hopkins University
Trial IDNCT07225998
Study typeInterventional
Trial phasePhase 2
Enrollment40 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 11, 2026, 12:00 AM
Content availableTrial registry record
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.
Key Genes Linked to Biological Patterns of Crohn's Disease Progression Identified
Identifies gene and microbiome patterns linked to progression from inflammation to irreversible bowel fibrosis in Crohn’s disease, which could eventually help predict who is at higher risk and inform prevention...
Can a Personalized Anti-Inflammatory Diet Reduce Crohn's Disease Inflammation?
Many people with Crohn’s disease have ongoing inflammation despite stable medication. If dietary personalization can reduce inflammation, it could offer a nonpharmacologic add-on to help bridge gaps without immediate...
Site specific gene-microbial interactions in children with early-onset Crohn’s disease
Understanding gene–microbe interactions that drive site-specific disease in very early-onset Crohn’s could reveal why some children develop ileal versus colonic disease and suggest new approaches to prevention or...