Crohn'sNot yet recruiting

Oral N-acetylglucosamine in Crohn's Disease

Phase 2 · Testing N-Acetylglucosamine (GlcNAc) · 1 site · Johns Hopkins University

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing N-Acetylglucosamine (GlcNAc) (a drug) as a possible treatment. Condition(s) listed: Crohns Disease.

Participants are assigned to groups by chance (randomized).

It is blinded: participants and the study team do not know who receives what.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

Ages 18 to 80
Any sex

Some of the main requirements, copied from the record:

Age 18 and 80 years of age
Diagnosis of CD involving ileum (L1) or ileocolonic disease (L3) of any disease behavior
On stable dosing of any CD therapy for >/= 8 weeks (inclusive of biologics, small molecules, immunomodulators)

Plus 8 more requirement(s). There are also 20 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 40 participants are expected to take part.
Start date: 2026-11-01 (planned).
Main results expected around 2028-07-31 (estimate from the record).
1 study site listed in United States.

Main thing being measured

Safety and tolerability: Number of Crohn's disease exacerbations (Weeks 0-6, Weeks 6-9, Weeks 9-15, Weeks 15-18)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional
Conditions	Crohns Disease
Lead sponsor	Johns Hopkins University
Collaborators	Leona M. & Harry B. Helmsley Charitable Trust; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment	40 (estimated)
Start date	2026-11-01
Primary completion (est.)	2028-07-31
First posted	2025-11-10
Last updated	2026-09-11
Official title	The NAGIC Study: Multi-center, Randomized, Double-blind, Placebo-controlled Cross-over Study of Oral N-acetylglucosamine in Ileal/Ileocolonic Crohn's Disease
ClinicalTrials.gov ID	NCT07225998

Interventions

N-Acetylglucosamine (GlcNAc) (Drug)
This is a placebo-controlled, cross-over design. The sequence in which the participant receives the GlcNAc or placebo is randomized. Participants will take GlcNAc 2 grams three times daily or placebo (glucose 2 grams three times daily) for 6 weeks. There will then be a 3 week washout period and then cross-over to GlcNAc or placebo for 6 weeks. Participants will be followed for 3 weeks off all drug…

Full eligibility criteria (from the record)

Inclusion Criteria:

1. Age 18 and 80 years of age
2. Diagnosis of CD involving ileum (L1) or ileocolonic disease (L3) of any disease behavior
3. On stable dosing of any CD therapy for >/= 8 weeks (inclusive of biologics, small molecules, immunomodulators)
4. CDAI <450
5. Willing to undergo genetic testing for ZIP8 genotype
6. No steroids within the past 4 weeks
7. No antibiotics within the past 2 weeks
8. Willing to provide informed consent
9. Willing to participate in all at-home and clinic-based follow-up
10. Willing to provide most recent endoscopy and imaging results; when possible, access to prior pathology specimens
11. Willing to use all forms of "highly effective" contraception throughout the study period and for 30 days after the last dose of study drug (all subjects of child-bearing potential)

Exclusion criteria

1. Have taken GlcNAc or glucosamine in the previous 3 months
2. Allergy to shellfish
3. Severely-active CD defined as CDAI >450 AND/OR
4. Simple Endoscopic Score for Crohn's Disease (SES-CD) score >/= 16 (or >/= 8 for isolated ileitis) on colonoscopy within 8 weeks of screening, if available
5. Steroids within the past 4 weeks
6. Antibiotics within the past 2 weeks
7. Stricture with high-grade obstruction, significant fistulizing disease, presence of intra-abdominal or perianal abscess, perforation, or fulminant colitis requiring imminent surgical management
8. Surgery within 12 weeks
9. Recent initiation or escalation of immunosuppressive therapy (<8 weeks)
10. Any clinically significant abnormalities on routine clinical labs, including unexplained white blood cells (WBC) >16,000, hemoglobin <7, AST/ALT >2x ULN, alkaline phosphatase >2x ULN, eGFR <60, ferritin <30 ng/ml2
11. History of type 1 diabetes, inadequately controlled type 2 diabetes (HbA1c>6.5%), type 2 diabetes on insulin
12. History of peripheral vascular disease, coronary artery disease, stroke, transient ischemic attack
13. History of cancer
14. History of organ transplant
15. History of bleeding disorder
16. History of chronic respiratory disorder, including asthma
17. History of chronic renal failure
18. History of chronic liver disease, including primary sclerosing cholangitis
19. History of seizure disorder
20. Pregnant, less than 6 months postpartum, breastfeeding, or attempting to conceive

Locations (1)

Site	City	Country	Site status
Johns Hopkins University School of Medicine	Baltimore, Maryland	United States

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.