Acupuncture Treatment for Active Crohn's Disease

Effect of Acupuncture on Maintaining Active Crohn's Disease Intestinal Homeostasis Via Intestinal Microbiota and Peripheral Immunity: a Randomized Controlled Trial

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.

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.

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.