Clinical trial NCT06553053: Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
Official title: Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn's Disease Relapse
Inflammatory Bowel Diseases
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2024-08-14
Enrollment: 106
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to further improve the clinical efficacy of acupuncture in delaying the clinical recurrence of CD and to explore the efficacy mechanism of acupuncture efficacy enhancement.

Detailed description: Acupuncture has been proven to be an effective and safe treatment for CD. In this trial, based on previous studies, which mainly treated CD from the perspective of spleen and stomach tonification, we explored the therapeutic effect of acupuncture in treating CD from the perspective of tonifying the Shaoyang pivot mechanism to enhance the therapeutic effect.Brain-gut axis dysfunction is one of the important pathogenic mechanisms of CD. This trial attempted to explore the therapeutic targets and efficacy mechanisms of acupuncture to enhance CD by analysing brain-gut axis multi-pathway indicators.

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.

Primary outcomes:
measure: The proportion of recurrences
timeFrame: Week 52
Secondary outcomes:
measure: Number of recurrences
timeFrame: Week 52
measure: Time of recurrences
timeFrame: Week 52
measure: Crohn's disease activity index （CDAI）score
timeFrame: Week 0, 6, 12, 24, 36 and 52
measure: Patient Reported Outcome （PRO2）
timeFrame: Week 0, 6, 12, 24, 36 and 52
measure: First laboratory tests
timeFrame: Week 0, 6, 12, 24, 36 and 52
measure: Second laboratory tests
timeFrame: Week 0, 6, 12, 24, 36 and 52
measure: Third laboratory tests
timeFrame: Week 0, 6, 12, 24, 36 and 52
measure: Inflammatory bowel disease questionnaire (IBDQ)
timeFrame: Week 0, 12, 24, 36 and 52
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Week 0, 12, 24, 36 and 52
measure: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Week 0, 12, 24, 36 and 52
measure: Colonoscopy or small bowel MR evaluation
timeFrame: Week 0 and 52
measure: Expectation of acupuncture treatment
timeFrame: Week 0
measure: Blind questionnaire
timeFrame: Week 6 and 12
Other outcomes:
measure: Effects of acupuncture on brain network connectivity properties
timeFrame: Week 0 and 12
measure: Salivary cortisol
timeFrame: Week 0 and 12
measure: α-Salivary Amylase
timeFrame: Week 0 and 12
measure: Serum cortisol
timeFrame: Week 0 and 12
measure: Effect of acupuncture on autonomic nervous activity
timeFrame: Week 0 and 12
measure: Effect of acupuncture on intestinal inflammation levels function
timeFrame: Week 0 and 12
measure: Effect of acupuncture on intestinal mucosal barrier function
timeFrame: Week 0 and 12
Locations:
city: Shanghai
country: China
facility: Shanghai Research Institute of Acupuncture and Meridian
Study officials:
affiliation: Shanghai University of TCM
name: Bao Chunhui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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