Chondroitin Sulfate for Crohn's Disease

A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01245088

Enrollment

Registered

2010-11-22

Start date

2011-01-31

Completion date

2012-05-31

Last updated

2012-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's disease, chondroitin sulfate

Brief summary

Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed through serum and tissue cytokine analysis. Secondary endpoints are evidence of clinical effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.

Interventions

DRUGchondroitin sulfate

400 mg orally three times daily for 8 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 1\. Colonic or ileocolonic CD diagnosed for at least 3 months. 2. Active CD, defined as a Crohn's Disease Activity Index (CDAI; Appendix A) \[Best 1976\] of greater than 200 but less than 320 at the time entry into the study. 3\. Age \> 18 years. 4. Patients receiving oral or topical 5-aminosalicylates must be on a stable dose for four weeks prior to enrollment. 5\. Patients on azathioprine, 6-mercaptopurine, or methotrexate must be on stable doses for 14 weeks prior to enrollment. 6\. Patients on corticosteroids must be on stable doses for 2 weeks prior to enrollment. 7\. Patients receiving corticosteroid enemas must be on a stable dose for 3 weeks prior to enrollment. 8\. Patient on biologic therapy with infliximab, adalimumab, or certolizumab must be on stable therapy for 12 weeks prior to enrollment 9. Patient must sign informed consent.

Exclusion criteria

* 1\. Patients with only small bowel CD, fistulizing CD, or gastroduodenal CD without colonic involvement. 2\. Patients with known ulcerative colitis. 3. Patients expected to require surgery within 30 days for complications of CD. 4. Patients with CD and an intraabdominal abscess. 5. Patients requiring continuous antibiotics; antibiotics may be taken up to the point of enrollment into the study. 6\. Patients with severe cardiac, pulmonary, or renal disease. 7. Patients with a h/o malignancy other than resected basal cell carcinoma of the skin 8. Patients who have participated in another clinical research study in the past 8 weeks. 9\. Patients who are pregnant.

Design outcomes

Primary

Measure	Time frame
Biologic effect on inflammation	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026