Acupuncture to prevent Crohn's disease relapse

Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial

This study is testing if acupuncture can help people with Crohn's disease stay in remission longer by improving their body's energy and balance.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 16 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Shanghai)
• Trial ID: NCT06553053 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of acupuncture in delaying the recurrence of Crohn's disease (CD) by focusing on the Shaoyang pivot mechanism. It builds on previous findings that acupuncture is a safe and effective treatment for CD, aiming to enhance its therapeutic effects through a deeper understanding of the brain-gut axis dysfunction associated with the condition. Participants will receive specific acupuncture interventions designed to nourish the spleen and kidney while harmonizing the body's energy. The study will analyze various indicators to explore the mechanisms behind acupuncture's efficacy in treating CD.

Who should consider this trial

Good fit: Ideal candidates include patients aged 16-75 with a clinical diagnosis of Crohn's disease in remission who have experienced frequent relapses.

Not a fit: Patients with serious organic diseases, psychosis, or those currently pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the frequency of Crohn's disease relapses, improving patients' quality of life.

How similar studies have performed: Previous studies have shown acupuncture to be effective for Crohn's disease, but this specific approach focusing on the Shaoyang mechanism is novel.

Eligibility criteria

Inclusion Criteria:

1. patients with clinical diagnosis consistent with CD;
2. aged 16-75;
3. patients in remission (CDAI \< 150 and CRP \< 5mg/l, or Faecal calprotectin \< 50μg/g, or no ulcer under endoscopy);
4. patients with frequent disease recurrences (≥2) in the past years;
5. patients were not taking medication or were only taking one or more of the following drugs: \[mesalazine (≤4g/d), prednisone (≤15mg/d), azathioprine (≤1mg/kg/d)\] and prednisone and mesalazine were used for at least 1 month, while azathioprine was used for at least 3 months; or those who had poor response or loss of response to biological preparations (anti-TNF-α, IL-12p40, α4β7);
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 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.

Where this trial is running

Shanghai

• Shanghai Research Institute of Acupuncture and Meridian — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Bao Chunhui, MD, PhD — Shanghai University of TCM
• Study coordinator: Bao Chunhui, MD, PhD

Conditions Crohn's Disease Relapse; Inflammatory Bowel Diseases