NCT06214078招募中不适用
A Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial of Nicotinamide Mononucleotide in the Treatment of Mild Ulcerative Colitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Clinical response rate
研究概览
简要总结
The goal of this clinical trial is to compare the safety and efficacy of nicotinamide mononucleotide (NMN) and placebo in patients with mild ulcerative colitis (UC). The main question it aims to answer is Whether NMN can alleviate the intestinal pathology of UC patients, so as to play a role in UC treatment or adjuvant therapy.
Participants will be randomized into two groups, an NMN group or a placebo group. Patients in the NMN group were treated with NMN intervention for 8 weeks. The placebo group received a placebo intervention for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old, ≤75 years old;
- •Clinical diagnosis of mild active UC patients, the diagnosis standard reference inflammatory bowel disease diagnosis and treatment of the consensus of opinion
- •Agreed to participate in this study, and sign the informed consent.
排除标准
- •Patients with ALT or AST more than 2 times the upper limit of normal, TBIL more than 2 times the upper limit of normal;
- •The creatinine clearance patients less than 60 ml/min.
- •The intestines or other parts have severely active infection patients need to use antibiotics or antiviral drugs;
- •Crohn's disease and intestinal tuberculosis and other chronic intestinal infectious disease, intestinal malignant tumor patients;
- •Pregnancy and lactation women;
- •People with diabetes or screening period more than 7.0 tendency for fasting glucose/L or glycosylated hemoglobin exceed 6.5%;
- •With serious mental illness, such as drugs and alcohol can't cooperate with the patients;
- •Participated in any other clinical investigator within 1 month before the screening period;
- •The researchers determine any other disease or condition is not suitable for patients participate in the study.
结局指标
主要结局
Clinical response rate
时间窗: 8 weeks
Clinical response was defined according to STRIDE II as a reduction of at least 50% in Patient Reported Outcomes 2 (PRO2) rectal bleeding and stool frequency.
次要结局
- Endoscopic remission rate(8 weeks)
- Histologic remission rate after 8 weeks of intervention(8 weeks)
- clinical remission rate(8 weeks)
- Biomarker target attainment rate(8 weeks)
研究者
研究点 (1)
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