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NCT07225998 · ClinicalTrials.gov registry record · Phase 2
Oral N-acetylglucosamine in Crohn's Disease
A Phase 2 study, sponsored by Johns Hopkins University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT07225998: Clinical Trial Phase 2 study, sponsored by Johns Hopkins University.
NCT07225998 is a Phase 2 study that has not yet begun recruiting, run by Johns Hopkins University. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225998, a Phase 2 study, has not yet begun recruiting, sponsored by Johns Hopkins University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
Protein glycosylation is a critical post-translational modification that regulates protein trafficking and protein-protein interactions impacting a host of physiological processes. There is a growing appreciation of glycosylation defects in chronic human diseases, including Crohns disease. Crohns disease (CD), and the related condition of ulcerative colitis, are chronic inflammatory bowel diseases (IBD) that impact 3.1 million Americans. While the development of medications has revolutionized care of CD patients, clinical remission is only achieved in \~40% of patients a therapeutic ceiling that has not changed in 20 years. These data underscore the need for new CD treatment strategies. The investigators are focused on understanding the role of defective N-glycosylation in CD, as an innovative strategy to identify and develop new therapeutics. Depending on ancestral background, 7-25% of CD patients carry a pathogenic, missense mutation in the manganese (Mn) transporter ZIP8 (rs13107325; ZIP8 A391T). ZIP8 regulates systemic Mn homeostasis with ZIP8 391-Thr causing a relative Mn insufficiency. Mn is a required metal cofactor for enzymes regulating key cellular processes, like N-glycosylation. In the gut, protein N-glycosylation plays key roles in host-pathogen interactions, inflammation, and cell-cell interactions. The investigator's central hypothesis is that in patients carrying ZIP8 391-Thr - CD is exacerbated by aberrant N-glycosylation and that this defect can be targeted by specific, safe therapy. Supporting this hypothesis, Mn levels are reduced (\~15%) in ZIP8 391-Thr allele carriers and this is associated with a decrease in complex N-glycan branching in plasma. Further, the investigators uncovered a microbiota signature in the ileal mucosa that implicated altered bile acid homeostasis in ZIP8 391-Thr carriers. To better understand CD in ZIP8 391 carriers, the investigators generated a knock-in mouse model of ZIP8 391-Thr (Zip8393T/393T). Like patient data, th
Interventions
- DRUG N-Acetylglucosamine (GlcNAc)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07225998
The ClinicalTrials.gov registry entry for NCT07225998 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which N-Acetylglucosamine (GlcNAc) is the first listed.
NCT07225998 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07225998 about?
NCT07225998 is a clinical study titled "Oral N-acetylglucosamine in Crohn's Disease". Protein glycosylation is a critical post-translational modification that regulates protein trafficking and protein-protein interactions impacting a host of physiological processes. There is a growing appreciation of glycosylation defects in chronic human diseases, including Crohns disease. Crohns di...
What is the current status of trial NCT07225998?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2026-06-30. Estimated completion is 2028-12-31.
What interventions are being tested in trial NCT07225998?
The interventions under investigation include: N-Acetylglucosamine (GlcNAc) (DRUG).
Who is sponsoring clinical trial NCT07225998?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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