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

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

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

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Intestinal Disorder
• Intervention / Treatment: Other: acupuncture

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunhui Bao, MD, PhD; Phone Number: +862164395973; Email: baochunhui789@126.com

Study Locations

• China
  • Shanghai, China, 2000
    • Recruiting
    • Guona Li
    • Contact: Guona Li; Phone Number: +862465161782; Email: liguonaaa@163.com
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai research institute of acupuncture and meridian
      • Contact: Chunhui Bao, Doctor; Phone Number: +862164395973; Email: baochunhui789@126.com
      • Principal Investigator: Huangan Wu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Acupuncture group; Participants receiving acupuncture and mild moxibustion.

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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Collaborators: Fudan University; Shanghai Jiao Tong University School of Medicine; Shanghai University of Traditional Chinese Medicine; Indiana University School of Medicine
• Investigators: Study Chair: Huangan Wu, MD, PhD, Shanghai research institute of acupuncture and meridian

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: acupuncture; Crohn's disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: ZYS2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No