Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Status: Completed

Conditions: Crohn Disease

Treatments: Other: Sham acupuncture; Other: Acupuncture treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06364722

ZYS2024-02

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 ≤ age ≤ 75 years, gender is not limited;
2. 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;
3. 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);
4. Those who have not used biologics within 3 months prior to study entry;
5. Those who have never received acupuncture treatment;
6. Understand, agree to participate in the study and sign an informed consent form.

Exclusion criteria

1. Patients who have recently prepared for pregnancy or are pregnant or breastfeeding;
2. Patients with severe organic pathology;
3. Patients with confirmed psychosis;
4. 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;
5. 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;
6. Those with severe intestinal fistulae, abdominal abscesses, intestinal stenosis and intestinal obstruction, perianal lesions (perianal abscesses, etc.), gastrointestinal haemorrhage, intestinal perforation and other complications;
7. Those suffering from short bowel syndrome, those who have undergone abdominal or gastrointestinal surgery within the last six months;
8. Those who are unable to perform acupuncture due to the presence of skin diseases or defects in the area selected for acupuncture.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

Subjects in this group will receive real acupuncture combined with real moxibustion.

Treatment:

Other: Acupuncture treatment

Sham group

Sham Comparator group

Description:

Subjects in this group will receive sham acupuncture combined with sham moxibustion.

Treatment:

Other: Sham acupuncture