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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-ornithine supplementation group | Experimental | 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. |
|
| control group | No Intervention | The control group did not receive additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Now Foods L-Ornithine Capsules | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic remission rate | Endoscopic remission is defined using the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score ranges from 0 to 60, where lower scores indicate less severe disease activity and higher scores indicate more severe disease activity. Endoscopic remission was defined as an SES-CD score ≤2. | 8 weeks |
| Clinical remission rate | Clinical remission is defined using the Crohn's Disease Activity Index (CDAI). The CDAI score ranges from 0 to approximately 600, where lower scores indicate less severe disease activity and higher scores indicate more severe disease activity. Clinical remission was defined as a CDAI score ≤150. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker target attainment rate | The target of inflammatory biomarkers is defined using the following scales:
The biomarker target attainment rate is the percentage of patients who meet all three criteria at the end of the 8-week period. |
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Inclusion Criteria:
Exclusion Criteria:
Participants who meet any of the following criteria are not eligible for inclusion in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyan Wang, MD | Contact | +8613974889301 | wangxiaoyan@csu.edu.cn | |
| Jie Hong, PHD | Contact | +8613585691936 | jiehong97@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyan Wang, MD | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Jie Hong, PHD | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
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| 8 weeks |