Clinical trial NCT02559037: Acupuncture Treatment for Active Crohn's Disease
Official title: Effect of Acupuncture on Maintaining Active Crohn's Disease Intestinal Homeostasis Via Intestinal Microbiota and Peripheral Immunity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: acupuncture
moxibustion
intestinal microbiota
Peripheral immunity
Brain functional and structural changes
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
name: Changhai Hospital
First posted: 2015-09-24
Enrollment: 66
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: The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.

Detailed description: 1. A randomized controlled trial.
2. Acupuncture and moxibustion treatment, placebo control.
3. To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease.
4. To observe the effect on the regulation of intestinal microbiota in Crohn's disease.
5. To observe the effect on the regulation of peripheral immunity in Crohn's disease.
6. To observe the effect on the regulation of brain function and structure in Crohn's disease.

Eligibility criteria: Inclusion Criteria:

1. meet the diagnostic criteria of Crohn's disease;
2. age 16-70 years old;
3. patients with mild or moderate disease (150\<CDAI\<450) and evidence of active inflammation: serum C-reactive protein concentration ≥5 mg/L, fecal calprotectin concentration ≥250 μg/g, or obvious endoscopic evidence of ulcerations during the screening period of past 4 weeks;
4. patients who were not responsive, intolerant, dependent, or refused to use any one of the following medications: mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), and anti-TNF-α agents;
5. did not take or take one or more of the following drugs: prednisone \<15 mg/d for at least one month, azathioprine (\<1 mg/kg/d), methotrexate (\<15 mg/week), or mesalazine (\<4 g/d) for at least 3 months;
6. no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;
7. no previous history of receiving acupuncture;
8. provision of written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, and those desirous of conceiving in the near future;
2. patients with severe organic diseases;
3. patients with mental illness;
4. patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;
5. patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;
6. patients with severe extraintestinal manifestations, such as severe skin diseases, eye diseases, or thromboembolic diseases;
7. severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal abscess, gastrointestinal bleeding, bowel perforation, or other complications;
8. patients with short bowel syndrome;
9. patients with a history of abdominal or gastrointestinal surgery in the past six months;
10. patients with skin diseases or defects at the sites of acupuncture that prevents the application of acupuncture.

Primary outcomes:
measure: The proportion of patients with clinical remission
timeFrame: Week 12
Secondary outcomes:
measure: The proportion of patients with clinical remission
timeFrame: Week 24, 36 and 48
measure: The proportion of patients with clinical response
timeFrame: Week 12, 24, 36 and 48
measure: the mean change of CDAI from baseline
timeFrame: Week 12, 24, 36 and 48
measure: Laboratory tests for disease activity
timeFrame: Week 12, 24, 36 and 48
measure: Laboratory tests for disease activity
timeFrame: Week 12, 24, 36 and 48
measure: Laboratory tests for disease activity
timeFrame: Week 12, 24, 36 and 48
measure: Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Week 12 and 24
measure: Psychological factors on the Hospital anxiety and depression scale (HADS)
timeFrame: Week 12 and 24
measure: The mean change of Crohn's disease endoscopic index of severity (CDEIS)
timeFrame: Week 48
measure: Fecal calprotectin tests for disease activity
timeFrame: Week 12
measure: Histological scores for pathogenic manifestations
timeFrame: Week 48
measure: The proportion of clinical recurrences
timeFrame: Week 24，36 and 48
measure: Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
timeFrame: Week 12, 24，36 and 48
measure: Subgroup analysis of the main outcome measure
timeFrame: Week 12
Other outcomes:
measure: Intestinal microbiota
timeFrame: Week 12
measure: Plasma inflammatory cytokine levels
timeFrame: Week 12
measure: Intestinal barrier function
timeFrame: Week 12
measure: Brain functional changes
timeFrame: Week 12
measure: Brain structural changes
timeFrame: Week 12
measure: Correlation analysis of the change of CRP level and intestinal flora and plasma inflammatory levels at the end of acupuncture treatment
timeFrame: Week 12
measure: Correlation analysis of the change of CRP level and and brain structure and function
timeFrame: Week 12
measure: Correlation analysis of intestinal flora and brain structure and function
timeFrame: Week 12
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian
state: Shanghai
Study officials:
affiliation: Shanghai University of TCM
name: Huangan Wu, MD,PhD
role: STUDY_CHAIR
References:
citation: Bao C, Wu L, Wang D, Chen L, Jin X, Shi Y, Li G, Zhang J, Zeng X, Chen J, Liu H, Wu H. Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial. EClinicalMedicine. 2022 Feb 12;45:101300. doi: 10.1016/j.eclinm.2022.101300. eCollection 2022 Mar.