Study on the mechanism of acupuncture for irritable bowel syndrome via brain-gut-intestinal microorganism axis based on fMRI and metagenome
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- ITMCTR2200005585
- Lead Sponsor
- Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) IBS patients: ? Meet the Rome III diagnostic criteria of IBS; ? Age 18-70; ? The course of disease is more than 6 months; (4) Lack of morphological changes and biochemical abnormalities that could explain symptoms; ? Did not use any medication for IBS at least 2 weeks before treatment (except emergency treatment); ? 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; ? Voluntarily participate in the study and sign the informed consent.
(2) Healthy subjects: ? 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; ? Regular work and rest, no smoking, drug, alcohol abuse history, no drug abuse history. ? Antibiotics were prohibited until the end of the study; ? 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.
? 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.;
? 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;
? Have a history of abdominal or rectoanal surgery;
? Women during pregnancy, lactation and postpartum =12 months;
? Metal allergy or severe fear of needles.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fecal sample metagenomic sequencing bacterial community structure species abundance;Low frequency fluctuation amplitude of resting state fMRI;
- Secondary Outcome Measures
Name Time Method Changes in metagenomic integration of metabolic networks in fecal samples;Resting state functional magnetic resonance imaging (FMRI) activates brain regions;Resting state functional magnetic resonance imaging (RS-FMRI) functional connection;The SAS Anxiety Scale;IBS-SSS;Local consistency of resting state fMRI;