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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187820
• Other study ID #: ZYS2019-01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: Chunhui Bao, MD, PhD
• Phone: +862164395973
• Email: baochunhui789[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

1. Effect of acupuncture on symptoms of CD

2. Effect of acupuncture on brain functional activity of CD

3. Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD

4. Screen the brain image markers of acupuncture in the treatment of CD

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

1. aged 16-70;

2. patients with mild or moderate active disease (150 = CDAI < 450);

3. patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;

4. 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;

5. those who did not use anti-TNF alpha and other agents within 3 months before entering the study;

6. those who have never experienced acupuncture;

7. patients signing informed consent.

Exclusion Criteria:

1. patients who are recently pregnant or in pregnancy or lactation;

2. patients with serious organic diseases;

3. patients diagnosed as psychosis;

4. 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;

5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;

6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;

7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;

8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Intestinal Disorder

Intervention

Other:
• acupuncture
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.

Locations

Country	Name	City	State
China	Guona Li	Shanghai
China	Shanghai Research Institute of Acupuncture and Meridian	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian	Fudan University, Indiana University School of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of intestinal microbes	Application of 16S sequencing to analyze the gut microbial composition, structure and diversity of patients.	Week 12
Other	Analysis of the association between gut microbes, brain imaging and behavior	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
Other	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
Other	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
Primary	Clinical remission	Crohn's disease activity index (CDAI)less than 150 and decreased more than 70	Week 12
Secondary	Clinical remission	Crohn's disease activity index (CDAI) less than 150 and decreased more than 70	Week 24, 36 and 48
Secondary	Clinical response	Crohn's disease activity index (CDAI) decreased more than 70	Week 12, 24, 36 and 48
Secondary	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
Secondary	laboratory test	serum C-reactive protein (CRP) level	Week 12, 24, 36 and 48
Secondary	laboratory test	Erythrocyte sedimentation rate (ESR)	Week 12, 24, 36 and 48
Secondary	laboratory test	Platelet count	Week 12, 24, 36 and 48
Secondary	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
Secondary	Crohn's disease endoscopic index of severity (CDEIS)	The mean change in CDEIS from baseline	Week 48
Secondary	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
Secondary	The proportion of recurrences	Defined as CDAI > 150 and increase = 70 points or need to adjust drug to control disease condition.	Week 48
Secondary	Brain functional and structural changes	measured by functional MRI	Week 12
Secondary	Plasma and intestinal TRP-KYN metabolism level	Plasma and intestinal Indoleamine2,3dioxygenase 1 (IDO1)level	Week 12
Secondary	Plasma and intestinal TRP-KYN metabolism level	Plasma and intestinal Tryptophan (TRP) level	Week 12
Secondary	Plasma and intestinal TRP-KYN metabolism level	Plasma and intestinal kynurenine (KYN)level	Week 12
Secondary	Plasma and intestinal TRP-KYN metabolism level	Plasma and intestinal kynurenic acid (KYNA) level	Week 12
Secondary	Plasma and intestinal TRP-KYN metabolism level	Plasma and intestinal quinolinic acid (QUIN) level	Week 12
Secondary	Plasma and intestinal TRP-KYN metabolism level	Plasma and intestinal IFN-gamma level	Week 12
Secondary	Plasma and intestinal TRP-KYN metabolism level	Plasma and intestinal IL-1beta level	Week 12
Secondary	Plasma and intestinal TRP-KYN metabolism level	Plasma and intestinal IL-18 level	Week 12