NCT06455267

Preliminary Clinical Study on the Effect of L-ornithine on the Efficacy of Ustekinumab in Patients With Crohn's Disease

A Single Center, Randomized Controlled Clinical Study on the Effect of L-ornithine on the Efficacy of Ustekinumab in Patients With Crohn's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Third Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effect of supplementing L-ornithine compared to the control group on the efficacy of Ustekinumab in patients with Crohn's disease, and to summarize the role of supplementing L-ornithine in the treatment of CD patients. Participants will be randomized into two groups: the L-ornithine supplementation group and the control group. The patients in the L-ornithine supplementation group received oral ornithine capsules for 8 weeks. The control group did not receive additional intervention. Follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.

Detailed description

The goal of this clinical trial is to evaluate the effect of supplementing L-ornithine compared to the control group on the efficacy of Ustekinumab in patients with Crohn's disease, and to summarize the role of supplementing L-ornithine in the treatment of CD patients. Participants will be randomized into two groups: the L-ornithine supplementation group and the control group. Patients in the L-ornithine supplementation group take oral ornithine capsules twice a day, three capsules per time, for 8 weeks, each containing 500mg of L-ornithine. The control group did not receive additional intervention. Follow up once a week, and after the study, patients will come to the hospital to finish the evaluation indicators.

Conditions

• Mild to Severe Crohns Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Now Foods L-Ornithine Capsules	L-ornithine is an amino acid that helps the liver clear toxic ammonia and plays an important role in liver protection and treatment of hepatic encephalopathy. Now Foods L-ornithine capsules are an ornithine supplement containing 500mg of L-ornithine per capsule. Patients in the L-ornithine supplementation group take ornithine capsules orally twice a day, three capsules each time, for 8 weeks.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-05-01
• Completion: 2025-09-30
• First posted: 2024-06-12
• Last updated: 2024-06-12

Locations

1 site across 1 country: China