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

Primary Purpose

Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Disorder focused on measuring acupuncture, Crohn's disease

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai Research Institute of Acupuncture and MeridianRecruiting
  • Guona LiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture group

Arm Description

Participants receiving acupuncture and mild moxibustion.

Outcomes

Primary Outcome Measures

Clinical remission
Crohn's disease activity index (CDAI)less than 150 and decreased more than 70

Secondary Outcome Measures

Clinical remission
Crohn's disease activity index (CDAI) less than 150 and decreased more than 70
Clinical response
Crohn's disease activity index (CDAI) decreased more than 70
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.
laboratory test
serum C-reactive protein (CRP) level
laboratory test
Erythrocyte sedimentation rate (ESR)
laboratory test
Platelet count
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.
Crohn's disease endoscopic index of severity (CDEIS)
The mean change in CDEIS from baseline
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.
The proportion of recurrences
Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Brain functional and structural changes
measured by functional MRI
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal Indoleamine2,3dioxygenase 1 (IDO1)level
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal Tryptophan (TRP) level
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal kynurenine (KYN)level
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal kynurenic acid (KYNA) level
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal quinolinic acid (QUIN) level
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IFN-gamma level
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IL-1beta level
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IL-18 level

Full Information

First Posted
December 1, 2019
Last Updated
April 11, 2023
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators
Fudan University, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University School of Medicine, Indiana University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04187820
Brief Title
Effect of Acupuncture on Mild to Moderate Active Crohn's Disease
Official Title
Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Collaborators
Fudan University, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University School of Medicine, Indiana University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease
Keywords
acupuncture, Crohn's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
Participants receiving acupuncture and mild moxibustion.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical remission
Description
Crohn's disease activity index (CDAI)less than 150 and decreased more than 70
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Clinical remission
Description
Crohn's disease activity index (CDAI) less than 150 and decreased more than 70
Time Frame
Week 24, 36 and 48
Title
Clinical response
Description
Crohn's disease activity index (CDAI) decreased more than 70
Time Frame
Week 12, 24, 36 and 48
Title
Crohn's disease activity index (CDAI)score
Description
The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Time Frame
Week 12, 24, 36 and 48
Title
laboratory test
Description
serum C-reactive protein (CRP) level
Time Frame
Week 12, 24, 36 and 48
Title
laboratory test
Description
Erythrocyte sedimentation rate (ESR)
Time Frame
Week 12, 24, 36 and 48
Title
laboratory test
Description
Platelet count
Time Frame
Week 12, 24, 36 and 48
Title
Inflammatory bowel disease questionnaire (IBDQ)
Description
The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Time Frame
Week 12 and 24
Title
Crohn's disease endoscopic index of severity (CDEIS)
Description
The mean change in CDEIS from baseline
Time Frame
Week 48
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
Week 12 and 24
Title
The proportion of recurrences
Description
Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Time Frame
Week 48
Title
Brain functional and structural changes
Description
measured by functional MRI
Time Frame
Week 12
Title
Plasma and intestinal TRP-KYN metabolism level
Description
Plasma and intestinal Indoleamine2,3dioxygenase 1 (IDO1)level
Time Frame
Week 12
Title
Plasma and intestinal TRP-KYN metabolism level
Description
Plasma and intestinal Tryptophan (TRP) level
Time Frame
Week 12
Title
Plasma and intestinal TRP-KYN metabolism level
Description
Plasma and intestinal kynurenine (KYN)level
Time Frame
Week 12
Title
Plasma and intestinal TRP-KYN metabolism level
Description
Plasma and intestinal kynurenic acid (KYNA) level
Time Frame
Week 12
Title
Plasma and intestinal TRP-KYN metabolism level
Description
Plasma and intestinal quinolinic acid (QUIN) level
Time Frame
Week 12
Title
Plasma and intestinal TRP-KYN metabolism level
Description
Plasma and intestinal IFN-gamma level
Time Frame
Week 12
Title
Plasma and intestinal TRP-KYN metabolism level
Description
Plasma and intestinal IL-1beta level
Time Frame
Week 12
Title
Plasma and intestinal TRP-KYN metabolism level
Description
Plasma and intestinal IL-18 level
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
Analysis of intestinal microbes
Description
Application of 16S sequencing to analyze the gut microbial composition, structure and diversity of patients.
Time Frame
Week 12
Title
Analysis of the association between gut microbes, brain imaging and behavior
Description
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.
Time Frame
Week 12
Title
Acupuncture efficacy prediction
Description
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.
Time Frame
Week 48
Title
Disease activity prediction
Description
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.
Time Frame
Week 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunhui Bao, MD, PhD
Phone
+862164395973
Email
baochunhui789@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huangan Wu, MD, PhD
Organizational Affiliation
Shanghai Research Institute of Acupuncture and Meridian
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Research Institute of Acupuncture and Meridian
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunhui Bao, Doctor
Phone
+862164395973
Email
baochunhui789@126.com
First Name & Middle Initial & Last Name & Degree
Huangan Wu, Doctor
Facility Name
Guona Li
City
Shanghai
ZIP/Postal Code
2000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guona Li
Phone
+862465161782
Email
liguonaaa@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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