研究疾病:
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肠易激综合征
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研究疾病代码:
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Target disease:
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Irritable Bowel Syndrome
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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非随机对照试验
Non randomized control
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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探索针刺治疗肠易激综合征(IBS)的效应机制,通过与健康受试者对照,观察治疗前后静息态功能磁共振成像(rs-fMRI)下IBS脑功能改变,采用粪便样本宏基因测序观察肠道菌群改善情况,构建并筛选IBS肠道菌群宏基因组DNA文库,建立宏基因组整合代谢网络,研究针刺基于“脑-肠-菌”轴双向调节治疗IBS的机制。
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Objectives of Study:
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To explore the effect mechanism of acupuncture in the treatment of irritable bowel syndrome (IBS), by comparing with healthy subjects, the changes of brain function of IBS under rS-FMRI were observed before and after treatment, metagenome sequencing was used to observe the improvement of intestinal flora in fecal samples, and the metagenomic DNA library of INTESTINAL flora of IBS was constructed and screened. The metagenomic integrated metabolic network was established to study the mechanism of acupuncture in the treatment of IBS based on the "brain-intestinal-bacteria" axis.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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(1)IBS患者:①符合IBS罗马III诊断标准;②年龄 18-70岁;③病程6个月以上;④缺乏可解释症状的形态学改变和生化指标异常;⑤治疗前至少2周没有使用过任何治疗IBS的药物(应急处理除外);⑥近3个月未接受针对IBS的针灸治疗或精神类疾病治疗,且没有献血或参加其他药物临床试验;⑦自愿参加研究,签署知情同意书。
(2)健康受试者:①询问身体健康状况,并进行详细体检(体格检查、心电图及肝肾功能、血尿常规等实验室检查)证明身体健康;②作息规律,没有吸烟、药物、酒精滥用史,无吸毒史。③入组到研究结束前禁服抗生素类药物;④试验期间能遵守禁烟及酒、茶、咖啡等刺激性饮料摄入,禁止饮用酸奶等发酵乳制品。
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Inclusion criteria
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(1) IBS patients: ① Meet the Rome III diagnostic criteria of IBS; ② Age 18-70; ③ The course of disease is more than 6 months; (4) Lack of morphological changes and biochemical abnormalities that could explain symptoms; ⑤ Did not use any medication for IBS at least 2 weeks before treatment (except emergency treatment); ⑥ Did not receive acupuncture treatment for IBS or psychiatric treatment in the last 3 months, and did not donate blood or participate in clinical trials of other drugs; ⑦ Voluntarily participate in the study and sign the informed consent.
(2) Healthy subjects: ① Ask about their health status, and perform detailed physical examination (physical examination, electrocardiogram, liver and kidney function, routine hematuria and other laboratory tests) to prove that they are healthy; ② Regular work and rest, no smoking, drug, alcohol abuse history, no drug abuse history. ③ Antibiotics were prohibited until the end of the study; ④ During the test, the smoking ban, alcohol, tea, coffee and other stimulating drinks should be observed, and fermented dairy products such as yogurt should be prohibited.
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排除标准:
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①有报警症状的患者,如体检有异常发现,发热、体重减轻、便血,连续不间断的严重腹痛,时间持续超过 12 h/d,急性腹痛等;
②有影响消化道功能的全身疾病者(如胆囊胰腺炎、甲状腺功能亢进症、糖尿病、慢性肾功能不全、神经系统病变);
③合并有心血管系统、肝、肾、造血系统、精神疾病、认知功能明显障碍等严重原发性疾病者;
④有腹部或直肠肛门手术史者;
⑤妊娠、哺乳期、产后≤12个月妇女;
⑥金属过敏或严重惧针者。
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Exclusion criteria:
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① Patients with alarm symptoms, such as abnormal findings in physical examination, fever, weight loss, blood in the stool, continuous severe abdominal pain lasting more than 12 h/d, acute abdominal pain, etc.;
② Systemic diseases affecting digestive tract function (such as gallbladder pancreatitis, hyperthyroidism, diabetes, chronic renal insufficiency, neurological diseases);
(3) Patients with serious primary diseases such as cardiovascular system, liver, kidney, hematopoietic system, mental disease and obvious cognitive dysfunction;
④ Have a history of abdominal or rectoanal surgery;
⑤ Women during pregnancy, lactation and postpartum ≤12 months;
⑥ Metal allergy or severe fear of needles.
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研究实施时间:
Study execute time:
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从From
2021-10-31
至To
2022-10-31
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征募观察对象时间:
Recruiting time:
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从From
2022-03-01
至To
2022-06-01
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