Effect of L-ornithine on Ustekinumab for 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

This study is testing if adding L-ornithine to the treatment with Ustekinumab can help people with Crohn's disease feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Third Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: Ustekinumab
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06455267 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the impact of L-ornithine supplementation on the effectiveness of Ustekinumab in patients diagnosed with Crohn's disease. Participants will be randomly assigned to either receive L-ornithine capsules or no additional treatment for a duration of 8 weeks. Weekly follow-ups will be conducted to monitor progress, and evaluations will be completed at the end of the study period. The study seeks to clarify the role of L-ornithine in enhancing treatment outcomes for Crohn's disease patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 who have been clinically diagnosed with Crohn's disease and are currently receiving Ustekinumab.

Not a fit: Patients with severe liver dysfunction, significant renal impairment, or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment efficacy for patients with Crohn's disease who are undergoing Ustekinumab therapy.

How similar studies have performed: While the specific combination of L-ornithine and Ustekinumab has not been extensively tested, similar studies exploring adjunctive therapies for Crohn's disease have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old, ≤ 75 years old;
2. 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;
3. Patients receiving treatment with Ustekinumab;
4. Agree to participate in this study and sign an informed consent form.

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for inclusion in this study.

1. Patients with ALT or AST exceeding the normal upper limit by more than twice, and TBIL exceeding the normal upper limit by more than twice;
2. Patients with creatinine clearance rate less than 60ml/min;
3. Patients with severe active infections in the intestines or other areas that require the use of antibiotics or antiviral drugs;
4. Patients with intestinal tuberculosis, other chronic intestinal infectious diseases, and intestinal malignant tumors;
5. Pregnant and lactating women;
6. The fasting blood glucose of patients with diabetes or screening period exceeds 7.0mmol/L or glycosylated hemoglobin exceeds 6.5%;
7. Merge patients with severe mental illness, drug use, alcohol abuse, etc. who are unable to cooperate with the study;
8. Have participated in any other clinical research within the first month prior to enrollment;
9. The researcher determined that any other disease or condition is not suitable for patients participating in this study.

Where this trial is running

Changsha, Hunan

• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Xiaoyan Wang, MD — The Third Xiangya Hospital of Central South University
• Study coordinator: Xiaoyan Wang, MD

Conditions Mild to Severe Crohns Disease; Ustekinumab; L-ornithine