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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Shanghai University of Traditional Chinese Medicine | OTHER |
| Shanghai Jiao Tong University School of Medicine | OTHER |
| Indiana University |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Participants receiving acupuncture and mild moxibustion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission | Crohn's disease activity index （CDAI）less than 150 and decreased more than 70 | Week 12 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of intestinal microbes | Application of 16S sequencing to analyze the gut microbial composition, structure and diversity of patients. | Week 12 |
| Analysis of the association between gut microbes, brain imaging and behavior |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunhui Bao, MD, PhD | Contact | +862164395973 | baochunhui789@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Huangan Wu, MD, PhD | Shanghai Research Institute of Acupuncture and Meridian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Research Institute of Acupuncture and Meridian | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| OTHER |
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| 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 |
The pearson correlation and linear regression models were applied to establish the association between gut microbes, brain function and structure and behavior in an attempt to explore the relationship between the gut microbe-gut-brain axis in patients with active CD.
| Week 12 |
| Acupuncture efficacy prediction | Deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate an acupuncture efficacy prediction model based on MRI changes in high and low response patients in the acupuncture group, and to screen brain neuroimaging markers that predict the effective relief of CD disease activity by acupuncture. | Week 48 |
| Disease activity prediction | Differences in brain structure and functional activity between active CD patients and remitting CD patients as well as healthy subjects are measured, and deep learning algorithms such as artificial neural networks and support vector machines are applied to construct and validate disease diagnostic models and screen brain imaging markers that predict CD disease activity. | Week 0 |
| Guona Li | Recruiting | Shanghai | 2000 | China |
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