Clinical trial NCT04211129: Effect of Acupuncture on Patients With Crohn's Disease in Remission
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: SUSPENDED
Phase: NA
Conditions: Crohn Disease
Inflammatory Bowel Diseases
Keywords: acupuncture
Crohn's disease
brain functional activity
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Ruijin Hospital
name: Shanghai Mental Health Center
name: Indiana University School of Medicine
First posted: 2019-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity

Detailed description: 1. Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD
2. Effect of acupuncture on brain functional activity of CD

Eligibility criteria: Inclusion Criteria:

1. aged 16-70;
2. patients in remission (CDAI \< 150);
3. 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;
4. those who did not use TNF alpha and other preparations within 3 months before entering the study;
5. those who have never experienced acupuncture;
6. 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: Brief Fatigue Inventory (BFI-C)
timeFrame: Week 12
Secondary outcomes:
measure: Brief Fatigue Inventory (BFI-C)
timeFrame: Week 24,52
measure: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Week 12, 24,52
measure: Crohn's disease activity index （CDAI）score
timeFrame: Week 12, 24,36,48,52
measure: Inflammatory bowel disease questionnaire (IBDQ)
timeFrame: Week 12, 24 and 52
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Week 12, 24 and 52
measure: Patient Health Questionnaire Depression Scale (PHQ-9)
timeFrame: Week 12, 24 and 52
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Week 12, 24 and 52
measure: The proportion of recurrences
timeFrame: Week 52
measure: Brain functional and structural changes
timeFrame: Week 12
measure: Colonoscopy or small bowel MR evaluation
timeFrame: Week 52
measure: Laboratory tests
timeFrame: Week 12, 24, 36, and 52
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Research Institute of Acupuncture and Meridian
city: Shanghai
country: China
facility: Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine
Study officials:
affiliation: Shanghai Research Institute of Acupuncture and Meridian
name: Huangan Wu, MD, PhD
role: STUDY_CHAIR
References: