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Study on the mechanism of acupuncture for irritable bowel syndrome via brain-gut-intestinal microorganism axis based on fMRI and metagenome

Study on the mechanism of acupuncture for irritable bowel syndrome via brain-gut-intestinal microorganism axis based on fMRI and metagenome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005585
Enrollment
Unknown
Registered
2022-02-01
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Interventions

Sponsors

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medicine Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: ? 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.

Design outcomes

Primary

MeasureTime frame
Fecal sample metagenomic sequencing bacterial community structure species abundance;Low frequency fluctuation amplitude of resting state fMRI;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactJia Liu
marie_liujia@sina.cn18810877011

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026