NCT06364722Completed
Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease
Source: ClinicalTrials.gov · Last updated 15 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 29 Mar 2024
- Start date
- 1 May 2015
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Diseases
- Crohn's disease
- NCT number
- NCT06364722
What you commit to
- Study type: Interventional
- Participants enrolled: 64
- From 1 May 2015 to the primary completion date, 31 Dec 2023
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- 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;
- Those with severe intestinal fistulae, abdominal abscesses, intestinal stenosis and intestinal obstruction, perianal lesions (perianal abscesses, etc.), gastrointestinal haemorrhage, intestinal perforation and other complications;
- Those suffering from short bowel syndrome, those who have undergone abdominal or gastrointestinal surgery within the last six months;
- Those who are unable to perform acupuncture due to the presence of skin diseases or defects in the area selected for acupuncture.
Other
- Patients who have recently prepared for pregnancy or are pregnant or breastfeeding;
- Patients with severe organic pathology;
- Patients with confirmed psychosis;
Who the study is looking for
- 18 ≤ age ≤ 75 years, gender is not limited;
- 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;
- 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);
- Those who have not used biologics within 3 months prior to study entry;
- Those who have never received acupuncture treatment;
- Understand, agree to participate in the study and sign an informed consent form.
Age in the registry: 16 years to 75 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.