NCT06364722已完成不适用
Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease
Shanghai Institute of Acupuncture, Moxibustion and Meridian0 个研究点目标入组 64 人开始时间: 2015年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 主要终点
- Effect of Acupuncture on Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
Multidisciplinary techniques such as multimodal neuroimaging, microbiology, and bioinformatics were applied to study the differences in correlation characteristics between gut microbes, functional brain networks, and peripheral inflammation among patients with active Crohn's disease (CD), CD in remission, and healthy subjects.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects, efficacy assessors and statisticians were blinded.
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 ≤ age ≤ 75 years, gender is not limited;
- •Disease in mildly or moderately active stage: 150 ≤ CDAI < 450 and at least one of the following is met: serum C-reactive protein ≥ 5 mg/L, faecal calreticulin ≥ 250 μg/g, or endoscopic ulceration, or remission stage: CDAI < 150 and at least one of the following is met: serum C-reactive protein < 5 mg/L, faecal calreticulin < 250 μg/g, or endoscopic No ulcers;
- •Not taking or taking the following medications: mesalazine (≤4 g/d and have been taking for ≥1 month), prednisone (≤15 mg/d and have been taking for ≥1 month), and/or azathioprine (≤1 mg/kg/d and have been taking for ≥3 months);
- •Those who have not used biologics within 3 months prior to study entry;
- •Those who have never received acupuncture treatment;
- •Understand, agree to participate in the study and sign an informed consent form.
排除标准
- •Patients who have recently prepared for pregnancy or are pregnant or breastfeeding;
- •Patients with severe organic pathology;
- •Patients with confirmed psychosis;
- •Patients who are suffering from multiple diseases at the same time and taking other drugs for a long time which may affect the observation of this clinical trial;
- •Patients with severe extra-intestinal manifestations such as severe skin diseases (e.g., erythema nodosum, gangrenous pyoderma, etc.), ocular lesions (e.g., iritis, uveitis, etc.), and thromboembolic diseases;
- •Those with severe intestinal fistulae, abdominal abscesses, intestinal stenosis and intestinal obstruction, perianal lesions (perianal abscesses, etc.), gastrointestinal haemorrhage, intestinal perforation and other complications;
- •Those suffering from short bowel syndrome, those who have undergone abdominal or gastrointestinal surgery within the last six months;
- •Those who are unable to perform acupuncture due to the presence of skin diseases or defects in the area selected for acupuncture.
结局指标
主要结局
Effect of Acupuncture on Crohn's Disease Activity Index (CDAI)
时间窗: Week 12
Difference in Crohn's Disease Activity Index (CDAI) from baseline at 12 weeks was used for between-group assessment.
次要结局
- Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations(Week 12)
- Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment)(Week 12)
- Effects of Acupuncture on Anxiety and Depression(Week 12)
- Effects of acupuncture on the functional activity of brain networks(Week 12)
- Effects of acupuncture on intestinal inflammation(Week 12)
- Effect of acupuncture on intestinal inflammation(Week 12)
- Safety evaluation (number of participants with abnormal routine blood tests)(Week 12)
- Safety evaluation (number of participants with abnormal Liver function tests)(Week 12)
- Effects of Acupuncture on Quality of Life(Week 12)
- Effects of acupuncture on gut microbiota(Week 12)
- Safety evaluation (number of participants with abnormal Renal function tests)(Week 12)
研究者
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