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NCT Number: NCT04187820

Effect of Acupuncture on Mild to Moderate Active Crohn's Disease

To observe the clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD

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Key information

Conditions

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

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Research Institute of Acupuncture and Meridian, Shanghai, Shanghai Municipality, China

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About this study

  • Effect of acupuncture on symptoms of CD
  • Effect of acupuncture on brain functional activity of CD
  • Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD
  • Screen the brain image markers of acupuncture in the treatment of CD

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • aged 16-70;
  • patients with mild or moderate active disease (150 ≤ CDAI < 450);
  • patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
  • patients were not taking medication or were only taking one or more of the following drugs: [prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
  • those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
  • those who have never experienced acupuncture;
  • patients signing informed consent.

Exclusion criteria

  • patients who are recently pregnant or in pregnancy or lactation;
  • patients with serious organic diseases;
  • patients diagnosed as psychosis;
  • patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or 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.

Treatment and study plan

Acupuncture

Other

Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustIon.

Primary outcomes

  1. Clinical remission

    Time frame: Week 12

    Crohn's disease activity index （CDAI）less than 150 and decreased more than 70

Secondary outcomes

  1. Clinical remission

    Time frame: Week 24, 36 and 48

    Crohn's disease activity index （CDAI） less than 150 and decreased more than 70

  2. Clinical response

    Time frame: Week 12, 24, 36 and 48

    Crohn's disease activity index （CDAI） decreased more than 70

  3. Crohn's disease activity index （CDAI）score

    Time frame: Week 12, 24, 36 and 48

    The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.

  4. laboratory test

    Time frame: Week 12, 24, 36 and 48

    serum C-reactive protein (CRP) level

  5. laboratory test

    Time frame: Week 12, 24, 36 and 48

    Erythrocyte sedimentation rate (ESR)

  6. laboratory test

    Time frame: Week 12, 24, 36 and 48

    Platelet count

  7. Inflammatory bowel disease questionnaire (IBDQ)

    Time frame: Week 12 and 24

    The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.

  8. Crohn's disease endoscopic index of severity (CDEIS)

    Time frame: Week 48

    The mean change in CDEIS from baseline

  9. Hospital anxiety and depression scale (HADS)

    Time frame: Week 12 and 24

    The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.

  10. The proportion of recurrences

    Time frame: Week 48

    Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.

  11. Brain functional and structural changes

    Time frame: Week 12

    measured by functional MRI

  12. Plasma and intestinal TRP-KYN metabolism level

    Time frame: Week 12

    Plasma and intestinal Indoleamine2,3dioxygenase 1 （IDO1）level

  13. Plasma and intestinal TRP-KYN metabolism level

    Time frame: Week 12

    Plasma and intestinal Tryptophan (TRP) level

  14. Plasma and intestinal TRP-KYN metabolism level

    Time frame: Week 12

    Plasma and intestinal kynurenine （KYN）level

  15. Plasma and intestinal TRP-KYN metabolism level

    Time frame: Week 12

    Plasma and intestinal kynurenic acid （KYNA） level

  16. Plasma and intestinal TRP-KYN metabolism level

    Time frame: Week 12

    Plasma and intestinal quinolinic acid (QUIN) level

  17. Plasma and intestinal TRP-KYN metabolism level

    Time frame: Week 12

    Plasma and intestinal IFN-gamma level

  18. Plasma and intestinal TRP-KYN metabolism level

    Time frame: Week 12

    Plasma and intestinal IL-1beta level

  19. Plasma and intestinal TRP-KYN metabolism level

    Time frame: Week 12

    Plasma and intestinal IL-18 level

Other outcomes

  1. Analysis of intestinal microbes

    Time frame: Week 12

    Application of 16S sequencing to analyze the gut microbial composition, structure and diversity of patients.

  2. Analysis of the association between gut microbes, brain imaging and behavior

    Time frame: Week 12

    The pearson correlation and linear regression models were applied to establish the association between gut microbes, brain function and structure and behavior in an attempt to explore the relationship between the gut microbe-gut-brain axis in patients with active CD.

  3. Acupuncture efficacy prediction

    Time frame: Week 48

    Deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate an acupuncture efficacy prediction model based on MRI changes in high and low response patients in the acupuncture group, and to screen brain neuroimaging markers that predict the effective relief of CD disease activity by acupuncture.

  4. Disease activity prediction

    Time frame: Week 0

    Differences in brain structure and functional activity between active CD patients and remitting CD patients as well as healthy subjects are measured, and deep learning algorithms such as artificial neural networks and support vector machines are applied to construct and validate disease diagnostic models and screen brain imaging markers that predict CD disease activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Chunhui Bao, MD, PhD

CONTACT

[email protected]

+862164395973

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Collaborators

  • Fudan University
  • Indiana University
  • Shanghai Jiao Tong University School of Medicine
  • Shanghai University of Traditional Chinese Medicine

Registry information

Official study title

Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2019
Registry last updated
May 14, 2025

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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