Acupuncture Treatment for Active Crohn's Disease

• A randomized controlled trial.
• Acupuncture and moxibustion treatment, placebo control.
• To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease.
• To observe the effect on the regulation of intestinal microbiota in Crohn's disease.
• To observe the effect on the regulation of peripheral immunity in Crohn's disease.
• To observe the effect on the regulation of brain function and structure in Crohn's disease.

Inclusion criteria

• meet the diagnostic criteria of Crohn's disease;
• age 16-70 years old;
• 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;
• 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;
• 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;
• no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;
• no previous history of receiving acupuncture;
• provision of written informed consent.

Exclusion criteria

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