Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease

NCT06364722 | Completed DMC

• 1 other identifier: ZYS2024-02
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Multidisciplinary techniques such as multimodal neuroimaging, microbiology, and bioinformatics were applied to study the differences in correlation characteristics between gut microbes, functional brain networks, and peripheral inflammation among patients with active Crohn's disease (CD), CD in remission, and healthy subjects.

Conditions

Crohn Disease

Keywords

acupuncture; brain-gut interaction

Outcome Measures

Primary Outcomes (1)

• Effect of Acupuncture on Crohn's Disease Activity Index (CDAI)

  Difference in Crohn's Disease Activity Index (CDAI) from baseline at 12 weeks was used for between-group assessment.

  Week 12

Secondary Outcomes (11)

• Effects of Acupuncture on Anxiety and Depression

  Week 12

• Effects of Acupuncture on Quality of Life

  Week 12

• Effect of acupuncture on intestinal inflammation

  Week 12

• Effects of acupuncture on gut microbiota

  Week 12

• Effects of acupuncture on the functional activity of brain networks

  Week 12

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Subjects in this group will receive real acupuncture combined with real moxibustion.

Other: Acupuncture treatment

Sham group

SHAM COMPARATOR

Subjects in this group will receive sham acupuncture combined with sham moxibustion.

Other: Sham acupuncture

Interventions

Acupuncture treatment 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 group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age ≤ 75 years, gender is not limited;
• Disease in mildly or moderately active stage: 150 ≤ CDAI \< 450 and at least one of the following is met: serum C-reactive protein ≥ 5 mg/L, faecal calreticulin ≥ 250 μg/g, or endoscopic ulceration, or remission stage: CDAI \< 150 and at least one of the following is met: serum C-reactive protein \< 5 mg/L, faecal calreticulin \< 250 μg/g, or endoscopic No ulcers;
• Not taking or taking the following medications: mesalazine (≤4 g/d and have been taking for ≥1 month), prednisone (≤15 mg/d and have been taking for ≥1 month), and/or azathioprine (≤1 mg/kg/d and have been taking for ≥3 months);
• Those who have not used biologics within 3 months prior to study entry;
• Those who have never received acupuncture treatment;
• Understand, agree to participate in the study and sign an informed consent form.

You may not qualify if:

• Patients who have recently prepared for pregnancy or are pregnant or breastfeeding;
• Patients with severe organic pathology;
• Patients with confirmed psychosis;
• Patients who are suffering from multiple diseases at the same time and taking other drugs for a long time which may affect the observation of this clinical trial;
• Patients with severe extra-intestinal manifestations such as severe skin diseases (e.g., erythema nodosum, gangrenous pyoderma, etc.), ocular lesions (e.g., iritis, uveitis, etc.), and thromboembolic diseases;
• Those with severe intestinal fistulae, abdominal abscesses, intestinal stenosis and intestinal obstruction, perianal lesions (perianal abscesses, etc.), gastrointestinal haemorrhage, intestinal perforation and other complications;
• Those suffering from short bowel syndrome, those who have undergone abdominal or gastrointestinal surgery within the last six months;
• Those who are unable to perform acupuncture due to the presence of skin diseases or defects in the area selected for acupuncture.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead
• Fudan University: collaborator

MeSH Terms

Conditions

Crohn Disease

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects, efficacy assessors and statisticians were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 15, 2024
• Study Start: May 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: March 28, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share