Clinical trial NCT06375382: Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease
Official title: Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn Disease
Gastrointestinal Microbiome
Abdominal Pain
Acupuncture
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Crohn's disease is an intestinal inflammatory disease, causing abdominal pain, diarrhea and other symptoms. The intestinal flora disorder is closely related to the occurrence and development of Crohn's disease. Acupuncture can induce remission of Crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. This study is to screen the intestinal bacteria related to abdominal pain in CD, and explore the effects of acupuncture on the intestinal flora related to abdominal pain in CD patients.

Detailed description: 1. to screen the intestinal flora associated with CD abdominal pain.
2. to explore the effects of acupuncture and on abdominal pain and abdominal pain related intestinal flora in CD patients.

Eligibility criteria: Inclusion Criteria:

1. aged 18-75, no gender limit;
2. disease in mild and moderate active period: 150≤CDAI\<450 and meet at least one of the following: serum C-reactive protein (CRP) levels ≥5mg/L, Fecal calprotectin concentration≥250μg/g or endoscopic examination shows ulcers. remission period: CDAI \<150 and meet at least one of the following: serum CRP\<5 mg/L, Fecal calprotectin concentration \<250μg/g or endoscopic examination shows no ulcer;
3. patients were not taking medication or were only taking one or more of the following drugs: mesalazine (≤4g/d and mesalazine was used for at least 1 month), prednisone (≤15mg/d and prednisone was used for at least 1 month) and / or azathioprine (≤1mg/kg/d and azathioprine was used for at least 3 month);
4. those who have not used biologics within 3 months before entering the study;
5. those who have never experienced acupuncture;
6. those who understand and agree to participate in this study and sign the informed consent form.

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: Abdominal pain remission rate
timeFrame: Week 12
Secondary outcomes:
measure: Crohn's disease activity index （CDAI）
timeFrame: Week 12
measure: Hospital anxiety and depression scale (HADS)
timeFrame: Week 12
measure: Inflammatory bowel disease questionnaire (IBDQ)
timeFrame: Week 12
measure: Safety evaluation (number of participants with abnormal routine blood tests)
timeFrame: Week 12
measure: Safety evaluation (number of participants with abnormal Liver function tests)
timeFrame: Week 12
measure: Safety evaluation (number of participants with abnormal Renal function tests)
timeFrame: Week 12
Other outcomes:
measure: Gut microbiota composition structure and function
timeFrame: Week 12
measure: Correlation between changes in relative abundance of gut microbes and abdominal pain
timeFrame: Week 12
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study officials:
affiliation: Shanghai Institute of Acupuncture, Moxibustion and Meridian
name: Huangan Wu, PhD, MD
role: STUDY_CHAIR
References: