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
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age ≥ 18 years old, ≤ 75 years old;

• Patients clinically diagnosed with Crohn's disease shall refer to the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023) for diagnostic criteria;

• Patients receiving treatment with Ustekinumab;

• Agree to participate in this study and sign an informed consent form.

Locations
Other Locations
China
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
Xiaoyan Wang, MD
wangxiaoyan@csu.edu.cn
+8613974889301
Backup
Jie Hong, PHD
jiehong97@sjtu.edu.cn
+8613585691936
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 50
Treatments
Experimental: L-ornithine supplementation 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.
No_intervention: control group
The control group did not receive additional intervention.
Sponsors
Collaborators: RenJi Hospital
Leads: The Third Xiangya Hospital of Central South University

This content was sourced from clinicaltrials.gov