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

Not Applicable

Completed

• Conditions: Crohn Disease
• Interventions: Other: Acupuncture treatment; Other: Sham acupuncture

• Registration Number: NCT06364722
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-03
• Study Completion: 2024-03-28
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture group	Acupuncture treatment	Subjects in this group will receive real acupuncture combined with real moxibustion.
Sham group	Sham acupuncture	Subjects in this group will receive sham acupuncture combined with sham moxibustion.

Primary Outcome Measures

Name	Time	Method
Effect of Acupuncture on Crohn's Disease Activity Index (CDAI)	Week 12	Difference in Crohn's Disease Activity Index (CDAI) from baseline at 12 weeks was used for between-group assessment.

Secondary Outcome Measures

Name	Time	Method
Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations	Week 12	The effect of acupuncture was observed by constructing correlations between brain imaging parameters and gut microbiology and gut inflammation levels.
Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment)	Week 12	Abnormal reactions after acupuncture and moxibustion, such as bleeding, hematoma, scald, dizziness and other phenomena.
Effects of Acupuncture on Anxiety and Depression	Week 12	Differences in Hospital Anxiety Depression Scale (HADS) scores from baseline at 12 weeks were used for between-group assessment.
Effects of acupuncture on the functional activity of brain networks	Week 12	Including brain network graph theory properties, connection strength.
Effects of acupuncture on intestinal inflammation	Week 12	Including intestinal barrier function, peripheral Th1/Th17-related inflammatory factors.
Effect of acupuncture on intestinal inflammation	Week 12	Differences in serum C-reactive protein levels and faecal calprotectin levels from baseline at 12 weeks were used for between-group assessment.
Safety evaluation (number of participants with abnormal routine blood tests)	Week 12	Routine blood tests, which mainly include the number of red blood cells, white blood cells and platelets per litre of blood.
Safety evaluation (number of participants with abnormal Liver function tests)	Week 12	Liver function tests, mainly including peripheral blood concentrations of alanine aminotransferase (U/L), glutamine aminotransferase (U/L), gamma-glutamyl transpeptidase (U/L), alkaline phosphatase (U/L), total bilirubin (μmol/L), direct bilirubin (μmol/L), indirect bilirubin (μmol/L), total protein (g/L), albumin (g/L) and globulin (g/L).
Effects of Acupuncture on Quality of Life	Week 12	Differences in Inflammatory Bowel Disease Questionnaire (IBDQ) scores from baseline at 12 weeks were used for between-group assessment.
Effects of acupuncture on gut microbiota	Week 12	This includes the alpha and beta diversity of gut microbes and the abundance of flora at each level.
Safety evaluation (number of participants with abnormal Renal function tests)	Week 12	Renal function tests, mainly including tests of creatinine (μmol/L) and urea nitrogen (mmol/L) concentrations in peripheral blood.