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

NCT ID: NCT06455267

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Now Foods L-Ornithine Capsules

Intervention Type: DIETARY_SUPPLEMENT

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.

control group

The control group did not receive additional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Jie Hong, PHD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Wang, MD

Role: CONTACT

wangxiaoyan@csu.edu.cn

+8613974889301

Jie Hong, PHD

Role: CONTACT

jiehong97@sjtu.edu.cn

+8613585691936

Facility Contacts

Xiaoyan Wang, MD

Role: primary

wangxiaoyan@csu.edu.cn

+8613974889301

Jie Hong, PhD

Role: backup

jiehong97@sjtu.edu.cn

+8613585691936

Other Identifiers

2024-ORN-XY3

Identifier Type: -

Identifier Source: org_study_id