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Could a simple sugar ease Crohn's? new trial aims to find out

NCT ID NCT07225998

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether an oral supplement called N-acetylglucosamine (GlcNAc) can safely help control Crohn's disease in the ileum or ileocolon. Forty adults with stable Crohn's will receive either GlcNAc or a placebo for 6 weeks, then switch after a washout period. The study focuses on safety and symptom changes, and includes people with and without a specific genetic variant linked to the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
N-acetylglucosamine (GlcNAc)
What this could lead to
If it works, this could point toward a new treatment option for Crohn's disease, especially for patients with a specific genetic mutation.
What could go wrong
This is a small, early-phase proof-of-concept study. It may not show clear benefit, and results may not apply to all Crohn's patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205, United States

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Other studies related to the condition(s) this trial covers.