Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease

Not Applicable

Completed

• Conditions: Crohn Disease
• Interventions: Other: acupuncture; Other: Sham acupuncture

• Registration Number: NCT06375382
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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.

Study Timeline

• Study Start: 2015-03-01
• Primary Completion: 2023-12-31
• Status Verified: 2024-03
• Study Completion: 2024-03-31
• Study First Submitted: 2024-03-31
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture group	acupuncture	Receiving acupuncture and moxibustion
sham acupuncture group	Sham acupuncture	Receiving sham acupuncture and sham moxibustion

Primary Outcome Measures

Name	Time	Method
Abdominal pain remission rate	Week 12	The abdominal pain relief rate is the ratio of the number of subjects with abdominal pain relief at the end of 12 weeks of treatment to the total number of subjects.

Secondary Outcome Measures

Name	Time	Method
Hospital anxiety and depression scale (HADS)	Week 12	Difference in Hospital anxiety and depression scale (HADS) scores from baseline at 12 weeks was used for between-group assessment. The minimum score is 0, and the maximum score is 21. Higher scores mean a worse outcome.
Safety evaluation (number of participants with abnormal routine blood tests)	Week 12	Routine blood tests, which mainly include the number of red blood cells, white blood cells and platelets per litre of blood.
Safety evaluation (number of participants with abnormal Liver function tests)	Week 12	Liver function tests, mainly including peripheral blood concentrations of alanine aminotransferase (U/L), glutamine aminotransferase (U/L), gamma-glutamyl transpeptidase (U/L), alkaline phosphatase (U/L), total bilirubin (μmol/L), direct bilirubin (μmol/L), indirect bilirubin (μmol/L), total protein (g/L), albumin (g/L) and globulin (g/L).
Crohn's disease activity index （CDAI）	Week 12	Between-group assessment by difference in Crohn's Disease Activity Index (CDAI) at 12 weeks from baseline. The minimum value is 0 and there is no upper limit. 0-150: disease in remission; 151-220: mild active disease; 221-450: moderate active disease; values above 450: severe active disease. Higher scores mean a worse outcome.
Inflammatory bowel disease questionnaire (IBDQ)	Week 12	Differences in Inflammatory Bowel Disease Questionnaire (IBDQ) scores from baseline at 12 weeks were used for between-group assessment. The minimum score is 32, and the maximum score is 224. Higher scores mean a better outcome.
Safety evaluation (number of participants with abnormal Renal function tests)	Week 12	Renal function tests, mainly including tests of creatinine (μmol/L) and urea nitrogen (mmol/L) concentrations in peripheral blood.

Trial Locations

Locations (1)

Shanghai Institute of Acupuncture, Moxibustion and Meridian; 🇨🇳 Shanghai, China