Clinical trial NCT04187820: 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
Overall status: RECRUITING
Phase: NA
Conditions: Intestinal Disorder
Inflammatory Bowel Diseases
Crohn Disease
Keywords: acupuncture
Crohn's disease
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Shanghai University of Traditional Chinese Medicine
name: Shanghai Jiao Tong University School of Medicine
name: Indiana University School of Medicine
First posted: 2019-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical remission
timeFrame: Week 12
Secondary outcomes:
measure: Clinical remission
timeFrame: Week 24, 36 and 48
measure: Clinical response
timeFrame: Week 12, 24, 36 and 48
measure: Crohn's disease activity index （CDAI）score
timeFrame: Week 12, 24, 36 and 48
measure: laboratory test
timeFrame: Week 12, 24, 36 and 48
measure: laboratory test
timeFrame: Week 12, 24, 36 and 48
measure: laboratory test
timeFrame: Week 12, 24, 36 and 48
measure: Inflammatory bowel disease questionnaire (IBDQ)
timeFrame: Week 12 and 24
measure: Crohn's disease endoscopic index of severity (CDEIS)
timeFrame: Week 48
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Week 12 and 24
measure: The proportion of recurrences
timeFrame: Week 48
measure: Brain functional and structural changes
timeFrame: Week 12
measure: Plasma and intestinal TRP-KYN metabolism level
timeFrame: Week 12
measure: Plasma and intestinal TRP-KYN metabolism level
timeFrame: Week 12
measure: Plasma and intestinal TRP-KYN metabolism level
timeFrame: Week 12
measure: Plasma and intestinal TRP-KYN metabolism level
timeFrame: Week 12
measure: Plasma and intestinal TRP-KYN metabolism level
timeFrame: Week 12
measure: Plasma and intestinal TRP-KYN metabolism level
timeFrame: Week 12
measure: Plasma and intestinal TRP-KYN metabolism level
timeFrame: Week 12
measure: Plasma and intestinal TRP-KYN metabolism level
timeFrame: Week 12
Other outcomes:
measure: Analysis of intestinal microbes
timeFrame: Week 12
measure: Analysis of the association between gut microbes, brain imaging and behavior
timeFrame: Week 12
measure: Acupuncture efficacy prediction
timeFrame: Week 48
measure: Disease activity prediction
timeFrame: Week 0
Locations:
city: Shanghai
country: China
facility: Shanghai Research Institute of Acupuncture and Meridian
state: Shanghai
city: Shanghai
country: China
facility: Guona Li
Study officials:
affiliation: Shanghai Research Institute of Acupuncture and Meridian
name: Huangan Wu, MD, PhD
role: STUDY_CHAIR
References: