N-Acetylglucosamine for Crohn's Disease

(NAGIC-OL Trial)

Overseen By Joanna MP Melia, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must be taking: CD treatments

Must not be taking: GlcNAc, Glucosamine

Disqualifiers: Diabetes, Vascular disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supplement called N-acetylglucosamine (GlcNAc) can benefit individuals with Crohn's disease, a condition affecting the intestine. Researchers aim to determine if GlcNAc can improve issues with glycosylation, a cellular process linked to gut health and immune function in Crohn's. Participants will be divided into two groups based on a specific genetic trait that influences manganese levels, crucial for glycosylation. Individuals with Crohn's disease affecting the ileum who have not recently taken GlcNAc and are open to genetic testing may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop your current medications, but you must be on a stable dose of your Crohn's disease treatment for at least 8 weeks before starting. If you're on prednisone, you should plan to taper it over the first 6 weeks of the study.

Is there any evidence suggesting that oral N-acetylglucosamine is likely to be safe for humans?

Research has shown that oral N-acetylglucosamine (GlcNAc) is generally safe. Studies have found it particularly safe for individuals with inflammatory bowel diseases such as Crohn's disease. As GlcNAc is already available as a dietary supplement, most people can use it without issues. So far, studies have not reported any major serious side effects. In some early research, GlcNAc safely reduced symptoms in conditions like Crohn's disease and ulcerative colitis. This makes it a promising option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Unlike the standard treatments for Crohn's disease, which often include anti-inflammatory drugs, immune system suppressors, and biologics, N-acetylglucosamine is a different kind of therapy. It is a natural sugar that may offer a new way to manage the condition by potentially promoting mucosal healing in the gut. Researchers are excited because this approach might work by strengthening the intestinal barrier rather than suppressing the immune system, which could lead to fewer side effects. Additionally, this treatment is taken orally, which is generally more convenient for patients compared to infusions or injections.

What evidence suggests that oral N-acetylglucosamine might be an effective treatment for Crohn's disease?

Studies have shown that N-acetylglucosamine (GlcNAc) might improve gut health in people with Crohn's disease. In a small study, children with severe Crohn's who took GlcNAc experienced symptom relief. GlcNAc strengthens the gut lining and reduces inflammation. Another study suggested that inflammation in Crohn's disease links to changes in this process, and GlcNAc might help correct it. While more research is needed, early results are promising for those with Crohn's disease. Participants in this trial will receive N-acetylglucosamine, with one group consisting of those who carry the ZIP8 391-Thr variant and another group of those who do not. ^{1 4 6 7 8}

Who Is on the Research Team?

Joanna Melia, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with Crohn's disease, particularly those carrying a specific gene variant that affects manganese levels and increases the risk of ileum-involved Crohn's. Participants should have this genetic marker which is found in about 10% of people with Crohn's.

Inclusion Criteria

Willing to use all forms of FDA approved contraception (female participants of child-bearing age)

Willing to provide informed consent

I am willing to share my latest endoscopy and imaging results, and if possible, previous pathology samples.

Exclusion Criteria

Allergy to shellfish

Pregnant, less than 6 months postpartum, breastfeeding, or attempting to conceive

I am taking more than 20 mg of prednisone or its equivalent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive oral N-acetylglucosamine (GlcNAc) for 16 weeks, with weekly check-ins and 5 in-person visits

16 weeks

5 visits (in-person), weekly check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, including collection of blood, stool, and saliva samples

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Oral N-acetylglucosamine

Trial Overview The study tests oral N-acetylglucosamine (GlcNAc) on two groups divided by their gene variation. GlcNAc, a dietary supplement in the US, may improve glycosylation—a cellular process crucial for gut barrier function and immune response in Crohn's disease.

How Is the Trial Designed?

Group I: Participants with Crohn's disease who do not carry ZIP8 391-Thr Experimental Treatment 1 Intervention

N-acetylglucosamine

Group II: Participants with Crohn's disease and carry ZIP8 391-Thr (heterozygous or homozygous carriers) Experimental Treatment 1 Intervention

N-acetylglucosamine

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Leona M. & Harry B. Helmsley Charitable Trust

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225998

Oral N-acetylglucosamine in Crohn's Disease While many new medications improved care for patients with Crohn's disease, clinical remission is only achieved in ~40% of patients - a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7047186/

Enhanced O-linked Glcnacylation in Crohn's disease ... Taken together, our data suggest that intestinal inflammation in CD is associated with increased levels of O-GlcNAc, which is required for NF-κB ...

3. magistralbr.caldic.com magistralbr.caldic.com/storage/product-files/861963135.pdf

A pilot study of N-acetyl glucosamine, a nutritional ... Methods: GlcNAc (total daily dose 3±6 g) was admin- istered orally as adjunct therapy to 12 children with severe treatment-resistant inflammatory bowel disease.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8282940/

An observational cohort study to assess N- ... This study evaluated whether N-acetylglucosamine administered orally improves clinical outcomes for patients admitted to the hospital due to ...

5. researchgate.net researchgate.net/publication/12206608_A_pilot_study_of_N-acetyl_glucosamine_a_nutritional_substrate_for_glycosaminoglycan_synthesis_in_paediatric_chronic_inflammatory_bowel_disease

A pilot study of N-acetyl glucosamine, a nutritional ... Eight of the children given oral GlcNAc showed clear improvement, while four required resection. Of the children with symptomatic Crohn's ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2953398/

N-Acetylglucosamine: Production and Applications - PMC These experiments indicate that GlcNAc is a valuable compound with high safety in invaded, oral and topical usage. GlcNAc has been widely utilized as a ...

7. rxlist.com rxlist.com/supplements/n-acetyl_glucosamine.htm

N-acetyl Glucosamine: Health Benefits, Side Effects, Uses, ... There is some early evidence that N-acetyl glucosamine taken by mouth or rectally might decrease symptoms of IBD in children with Crohn's disease or ulcerative ...

8. meddatax.com meddatax.com/clinical-trials/NCT07225998

Oral N-acetylglucosamine in Crohn's Disease GlcNAc is preferred given its positive safety profile and prior small studies in patients with inflammatory bowel disease. Key study information ...