Effect of Acupuncture on Mild to Moderate Active Crohn's Disease

Study Overview
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Brief Summary
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To observe the clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD

Detailed Description
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Effect of acupuncture on symptoms of CD Effect of acupuncture on brain functional activity of CD Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD Screen the brain image markers of acupuncture in the treatment of CD

Official Title
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Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis

Conditions
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Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease

Intervention / Treatment
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* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 16-70; patients with mild or moderate active disease (150 ≤ CDAI < 450); patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation; patients were not taking medication or were only taking one or more of the following drugs: [prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months; those who did not use anti-TNF alpha and other agents within 3 months before entering the study; those who have never experienced acupuncture; patients signing informed consent. Exclusion Criteria: patients who are recently pregnant or in pregnancy or lactation; patients with serious organic diseases; patients diagnosed as psychosis; patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial; severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations; there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications; patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year; there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>Participants receiving acupuncture and mild moxibustion. | Other: acupuncture<br>* Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustIon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | Crohn's disease activity index （CDAI）less than 150 and decreased more than 70 | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission | Crohn's disease activity index （CDAI） less than 150 and decreased more than 70 | Week 24, 36 and 48 | 
| Clinical response | Crohn's disease activity index （CDAI） decreased more than 70 | Week 12, 24, 36 and 48 | 
| Crohn's disease activity index （CDAI）score | The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit. | Week 12, 24, 36 and 48 | 
| laboratory test | serum C-reactive protein (CRP) level | Week 12, 24, 36 and 48 | 
| laboratory test | Erythrocyte sedimentation rate (ESR) | Week 12, 24, 36 and 48 | 
| laboratory test | Platelet count | Week 12, 24, 36 and 48 | 
| Inflammatory bowel disease questionnaire (IBDQ) | The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224. | Week 12 and 24 | 
| Crohn's disease endoscopic index of severity (CDEIS) | The mean change in CDEIS from baseline | Week 48 | 
| Hospital anxiety and depression scale (HADS) | The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21. | Week 12 and 24 | 
| The proportion of recurrences | Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition. | Week 48 | 
| Brain functional and structural changes | measured by functional MRI | Week 12 | 
| Plasma and intestinal TRP-KYN metabolism level | Plasma and intestinal Indoleamine2,3dioxygenase 1 （IDO1）level | Week 12 | 
| Plasma and intestinal TRP-KYN metabolism level | Plasma and intestinal Tryptophan (TRP) level | Week 12 | 
| Plasma and intestinal TRP-KYN metabolism level | Plasma and intestinal kynurenine （KYN）level | Week 12 | 
| Plasma and intestinal TRP-KYN metabolism level | Plasma and intestinal kynurenic acid （KYNA） level | Week 12 | 
| Plasma and intestinal TRP-KYN metabolism level | Plasma and intestinal quinolinic acid (QUIN) level | Week 12 | 
| Plasma and intestinal TRP-KYN metabolism level | Plasma and intestinal IFN-gamma level | Week 12 | 
| Plasma and intestinal TRP-KYN metabolism level | Plasma and intestinal IL-1beta level | Week 12 | 
| Plasma and intestinal TRP-KYN metabolism level | Plasma and intestinal IL-18 level | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, Crohn's disease