RecruitingNot ApplicableNCT06455267

Preliminary Clinical Study on the Effect of L-ornithine on the Efficacy of Ustekinumab in Patients With 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


Sponsor

The Third Xiangya Hospital of Central South University

Enrollment

50 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether L-ornithine — an amino acid supplement — can improve the effectiveness of ustekinumab (a biologic drug that suppresses inflammation) in patients with Crohn's disease, a chronic inflammatory bowel condition. Researchers think L-ornithine may enhance how the immune system responds to the treatment. **You may be eligible if...** - You are aged 18–75 and have been clinically diagnosed with Crohn's disease - You are currently receiving ustekinumab as your treatment - You are willing to participate and sign a consent form **You may NOT be eligible if...** - You have significantly elevated liver enzymes or bilirubin (liver function abnormalities) - You have poor kidney function (creatinine clearance below 60 mL/min) - You have active severe intestinal infections or intestinal tuberculosis - You are pregnant or breastfeeding - You have poorly controlled diabetes (blood sugar or HbA1c above threshold) - You participated in another clinical trial within the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTNow 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.


Locations(1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT06455267


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