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

NCT06455267 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-06-12

No results posted yet for this study

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.

Conditions

  • Mild to Severe Crohns Disease

Interventions

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.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Xiaoyan Wang, MD · The Third Xiangya Hospital of Central South University

  • Jie Hong, PHD · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-05-01
Completion
2025-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455267 on ClinicalTrials.gov