Clinical trial NCT06364722: Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease
Official title: Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Keywords: acupuncture
brain-gut interaction
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: Fudan University
First posted: 2024-04-15
Enrollment: 64
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of Acupuncture on Crohn's Disease Activity Index (CDAI)
timeFrame: Week 12
Secondary outcomes:
measure: Effects of Acupuncture on Anxiety and Depression
timeFrame: Week 12
measure: Effects of Acupuncture on Quality of Life
timeFrame: Week 12
measure: Effect of acupuncture on intestinal inflammation
timeFrame: Week 12
measure: Effects of acupuncture on gut microbiota
timeFrame: Week 12
measure: Effects of acupuncture on the functional activity of brain networks
timeFrame: Week 12
measure: Effects of acupuncture on intestinal inflammation
timeFrame: Week 12
measure: Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations
timeFrame: Week 12
measure: Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment)
timeFrame: Week 12
measure: Safety evaluation (number of participants with abnormal routine blood tests)
timeFrame: Week 12
measure: Safety evaluation (number of participants with abnormal Liver function tests)
timeFrame: Week 12
measure: Safety evaluation (number of participants with abnormal Renal function tests)
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Institute of Acupuncture, Moxibustion and Meridian
name: Huangan Wu, PhD, MD
role: STUDY_CHAIR
References: