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

Registration number:

ITMCTR2200005585

Date of Last Refreshed on:

2022-02-01

Date of Registration:

2022-02-01

Registration Status:

Prospective registration

Public title:

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

English Acronym:

Scientific title:

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

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2200056159 ; ChiMCTR2200005585

Applicant:

Xue Cao

Study leader:

Jia Liu

Applicant telephone:

15056063326

Study leader's telephone:

18810877011

Applicant Fax:

Study leader's fax:

Applicant E-mail:

cxcy511@163.com

Study leader's E-mail:

marie_liujia@sina.cn

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, China

Study leader's address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, China

Applicant postcode:

Study leader's postcode:

Applicant's institution:

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

Approved by ethic committee:

Approved No. of ethic committee:

P21012/PJ12

Approved file of Ethical Committee:

View

Name of the ethic committee:

Ethics Committee of Institute of Clinical Basic Medicine of Chinese Medicine, China Academy of&#32

Date of approved by ethic committee:

2021/12/27 0:00:00

Contact Name of the ethic committee:

Contact Address of the ethic committee:

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

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

Primary sponsor's address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, China

Secondary sponsor:

Country:

China

Province:

Beijing

City:

Institution
hospital:

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

Address:

16 Nanxiao Street, Dongzhimennei, Dongcheng District, Beijing, China

Source(s) of funding:

Basic Research Funds of Institute of Clinical Basic Medicine of Chinese Medicine, China Academy of Chinese Medical Sciences (the fourteenth batch)

Target disease:

Irritable Bowel Syndrome

Target disease code:

Study type:

Interventional study

Study design:

Non randomized control

Study phase:

Pilot clinical trial

Objectives of Study:

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.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

(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.

Exclusion criteria:

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.

Study execute time:

From 2021-10-31

To      2022-10-31

Recruiting time:

From 2022-03-01

To      2022-06-01

Interventions:

5

Group:

The treatment group

Sample size:

Intervention:

Acupuncture

Intervention code:

Total sample size : 10

Countries of recruitment
and research settings:

Country:

China

Province:

Beijing

City:

Institution/hospital:

Guang 'anmen Hospital, China Academy of Chinese Medicine Sciences

Level of the institution:

Third class A Hospital of Traditional Chinese medicine

Outcomes:

Outcome:

Changes in metagenomic integration of metabolic networks in fecal samples

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Resting state functional magnetic resonance imaging (FMRI) activates brain regions

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Resting state functional magnetic resonance imaging (RS-FMRI) functional connection

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Fecal sample metagenomic sequencing bacterial community structure species abundance

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

The SAS Anxiety Scale

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

IBS-SSS

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Low frequency fluctuation amplitude of resting state fMRI

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Outcome:

Local consistency of resting state fMRI

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Feces

Tissue:

Fate of sample 

Destruction after use

Note:

Not yet recruiting

18
Min age years
70
Max age years

Recruiting status:

Participant age:

Gender:

Both

Randomization Procedure (please state who generates the random number sequence and by what method):

Non-randomized

Blinding:

IPD sharing:

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Upload the original data to this website 6 months after the end of the trial

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

CRF and Electronic Data Capture

Data Managemen Committee:

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above