Skip to main content
OpenTrials
Completed

NCT Number: NCT04198831

Effect of Acupuncture on Quiescent Crohn's Disease

To observe the clinical effect of acupuncture on quiescent Crohn's disease

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Bowel Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal 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, 200030, China

About this study

To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease

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 disease in remission: CDAI <150 and at least one of the following: serum C-reactive protein <5mg/L, fecal calprotectin <50μg/g or no ulcers on endoscopy;
  • Patients with more than 2 disease relapses in the past year;
  • 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. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. 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.

Sham Acupuncture

Other

Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion.

Primary outcomes

  1. The proportion of clinical relapse rates

    Time frame: Week 48

    Defined as a CDAI score of >150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.

Secondary outcomes

  1. Time of first relapse

    Time frame: Week 48

    Difference in time to first relapse between groups during the trial.

  2. Number of relapses

    Time frame: Week 48

    Difference in the number of relapses between groups during the trial.

  3. Moderate to severe clinical relapse rate

    Time frame: Week 48

    Defined as CDAI score ≥ 220; Differences in moderate to severe clinical recurrence rates between groups during the trial.

  4. The mean change of CDAI from baseline

    Time frame: Week 12, 24, 36 and 48

    Difference in the mean change of CDAI from baseline between groups

  5. The mean change of serum CRP level from baseline

    Time frame: Week 12, 24, 36 and 48

    Difference in the mean change of serum CRP level from baseline between groups

  6. The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: Week 12 and 24

    Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome.

  7. The mean change of the Hospital anxiety and depression scale (HADS)

    Time frame: Week 12 and 24

    Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome.

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

    Time frame: Week 48

    Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome.

Other outcomes

  1. brain structural and functional changes

    Time frame: Week 12

    brain functional and structural changes reflected by fMRI

  2. Intestinal microbiota

    Time frame: Week 12

    Changes in the structure and diversity of fecal microbiota detected by 16S rDNA sequencing.

  3. 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 CD in remission.

  4. 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 for brain neuroimaging markers that predict the effectiveness of acupuncture in delaying CD disease recurrence.

  5. Disease recurrence prediction

    Time frame: Week 0

    Differences in brain structure and functional activity between remitting CD patients with high relapse and remitting CD patients with low relapse as well as healthy subjects were measured, and deep learning algorithms such as artificial neural networks and support vector machines were applied to construct and validate diagnostic models of the disease and screen for brain imaging markers that predict disease recurrence in remitting CD.

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Collaborators

  • Fudan University
  • Indiana University
  • Ruijin Hospital
  • Shanghai University of Traditional Chinese Medicine

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2023
First posted
Dec 13, 2019
Registry last updated
Apr 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.