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Completed

NCT Number: NCT06364722

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 ≤ 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Week 12

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

Secondary outcomes

  1. Effects of Acupuncture on Anxiety and Depression

    Time frame: Week 12

    Differences in Hospital Anxiety Depression Scale (HADS) scores from baseline at 12 weeks were used for between-group assessment.

  2. Effects of Acupuncture on Quality of Life

    Time frame: Week 12

    Differences in Inflammatory Bowel Disease Questionnaire (IBDQ) scores from baseline at 12 weeks were used for between-group assessment.

  3. Effect of acupuncture on intestinal inflammation

    Time frame: Week 12

    Differences in serum C-reactive protein levels and faecal calprotectin levels from baseline at 12 weeks were used for between-group assessment.

  4. Effects of acupuncture on gut microbiota

    Time frame: Week 12

    This includes the alpha and beta diversity of gut microbes and the abundance of flora at each level.

  5. Effects of acupuncture on the functional activity of brain networks

    Time frame: Week 12

    Including brain network graph theory properties, connection strength.

  6. Effects of acupuncture on intestinal inflammation

    Time frame: Week 12

    Including intestinal barrier function, peripheral Th1/Th17-related inflammatory factors.

  7. Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations

    Time frame: Week 12

    The effect of acupuncture was observed by constructing correlations between brain imaging parameters and gut microbiology and gut inflammation levels.

  8. Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment)

    Time frame: Week 12

    Abnormal reactions after acupuncture and moxibustion, such as bleeding, hematoma, scald, dizziness and other phenomena.

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

    Time frame: Week 12

    Routine blood tests, which mainly include the number of red blood cells, white blood cells and platelets per litre of blood.

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

    Time frame: 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).

  11. Safety evaluation (number of participants with abnormal Renal function tests)

    Time frame: Week 12

    Renal function tests, mainly including tests of creatinine (μmol/L) and urea nitrogen (mmol/L) concentrations in peripheral blood.

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Collaborators

  • Fudan University

Registry information

Important dates

Study start
2015
Primary completion
2023
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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