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

NCT06375382 | Completed

• 1 other identifier: ZYS2024-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Keywords

Crohn Disease; Gastrointestinal Microbiome; Abdominal Pain; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Abdominal pain remission rate

  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.

  Week 12

Secondary Outcomes (6)

• Crohn's disease activity index （CDAI）

  Week 12

• Hospital anxiety and depression scale (HADS)

  Week 12

• Inflammatory bowel disease questionnaire (IBDQ)

  Week 12

• Safety evaluation (number of participants with abnormal routine blood tests)

  Week 12

• Safety evaluation (number of participants with abnormal Liver function tests)

  Week 12

Other Outcomes (2)

• Gut microbiota composition structure and function

  Week 12

• Correlation between changes in relative abundance of gut microbes and abdominal pain

  Week 12

Study Arms (2)

acupuncture group

EXPERIMENTAL

Receiving acupuncture and moxibustion

Other: acupuncture

sham acupuncture group

SHAM COMPARATOR

Receiving sham acupuncture and sham moxibustion

Other: Sham acupuncture

Interventions

acupuncture OTHER

We selected acupoints including Zhongwan (CV12) and bilateral Shangjuxu (ST37), Sanyinjiao (SP6), Gongsun (SP4), Taichong (LR3), Taixi (KI3), Hegu (LI4), and Quchi (LI11)17 according to the World Health Organization standard. Single-use 0.30×40 mm or 0.30×25 mm acupuncture needles (Hwato, Suzhou, China) 27,28 were vertically inserted into each acupoint to 20-30 mm depth to obtain a deqi sensation (a soreness, distention, numbness or heaviness sensation). Bilateral Zusanli (ST36) and Tianshu (ST25) were selected for moxibustion. Pure moxa sticks (diameter: 2.8 cm; Hanyi, Nanyang, China) were ignited and fixed on a moxibustion stand at a distance of 3-5 cm to the surface of acupoints. The temperature of skin surface at the acupoints was maintained at 43 ± 1°C and monitored with a miniature infrared thermometer (Fluke 62, Fluke Corporation, Everett, WA, USA). Acupuncture and moxibustion were concomitantly performed for 30 min.

acupuncture group

Sham acupuncture OTHER

Sham acupuncture needles (0.35×40 mm) with flat tips (Hwato, Suzhou, China) were inserted towards the same acupoints to induce slight pain but without penetrating the skin. Sham moxibustion was made by igniting the same type of moxa sticks but fixing them at a distance of 8-10 cm from the skin of acupoints to maintain the temperature at 37 ± 1°C. Sham acupuncture and moxibustion were concomitantly performed for 30 min.

sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-75, no gender limit;
• 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;
• 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);
• those who have not used biologics within 3 months before entering the study;
• those who have never experienced acupuncture;
• those who understand and agree to participate in this study and sign the informed consent form.

You may not qualify if:

• patients who are recently pregnant or in pregnancy or lactation;
• patients with serious organic diseases;
• patients diagnosed as psychosis;
• 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;
• severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
• there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
• patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
• there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Crohn Disease; Abdominal Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Huangan Wu, PhD, MD

  Shanghai Institute of Acupuncture, Moxibustion and Meridian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 19, 2024
• Study Start: March 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)