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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGEndoscopic 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.
Time frame: 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.
Time frame: 8 weeks
Biomarker target attainment rate
The target of inflammatory biomarkers is defined using the following scales: * C-Reactive Protein (CRP): CRP levels less than 5 mg/L. The CRP scale ranges from 0 to \>100 mg/L, with higher scores indicating higher levels of inflammation. * Erythrocyte Sedimentation Rate (ESR): ESR levels less than 15 mm/hr for men and less than 20 mm/hr for women. The ESR scale ranges from 0 to \>100 mm/hr, with higher scores indicating higher levels of inflammation. * Fecal Calprotectin (FC): FC levels decreased to 100-250 µg/g. The FC scale ranges from 0 to \>500 µg/g, with higher scores indicating higher levels of intestinal inflammation. The biomarker target attainment rate is the percentage of patients who meet all three criteria at the end of the 8-week period.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.