Crohn DiseaseNCT06364722
Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease
A study testing Acupuncture treatment in people with Crohn Disease, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Acupuncture treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Acupuncture treatment, Sham acupuncture
- Keywords
- acupuncture, brain-gut interaction
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture treatmentOther
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 acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Subjects in this group will receive real acupuncture combined with real moxibustion. Receives: Other: Acupuncture treatment |
| Sham group | Sham comparator | Subjects in this group will receive sham acupuncture combined with sham moxibustion. Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (11)
Effects of Acupuncture on Anxiety and Depression
Differences in Hospital Anxiety Depression Scale (HADS) scores from baseline at 12 weeks were used for between-group assessment.
Measured: Week 12
Effects of Acupuncture on Quality of Life
Differences in Inflammatory Bowel Disease Questionnaire (IBDQ) scores from baseline at 12 weeks were used for between-group assessment.
Measured: Week 12
Effect of acupuncture on intestinal inflammation
Differences in serum C-reactive protein levels and faecal calprotectin levels from baseline at 12 weeks were used for between-group assessment.
Measured: Week 12
Effects of acupuncture on gut microbiota
This includes the alpha and beta diversity of gut microbes and the abundance of flora at each level.
Measured: Week 12
Effects of acupuncture on the functional activity of brain networks
Including brain network graph theory properties, connection strength.
Measured: Week 12
Effects of acupuncture on intestinal inflammation
Including intestinal barrier function, peripheral Th1/Th17-related inflammatory factors.
Measured: Week 12
Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations
The effect of acupuncture was observed by constructing correlations between brain imaging parameters and gut microbiology and gut inflammation levels.
Measured: Week 12
Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment)
Abnormal reactions after acupuncture and moxibustion, such as bleeding, hematoma, scald, dizziness and other phenomena.
Measured: Week 12
Safety evaluation (number of participants with abnormal routine blood tests)
Routine blood tests, which mainly include the number of red blood cells, white blood cells and platelets per litre of blood.
Measured: Week 12
Safety evaluation (number of participants with abnormal Liver function tests)
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).
Measured: Week 12
Safety evaluation (number of participants with abnormal Renal function tests)
Renal function tests, mainly including tests of creatinine (μmol/L) and urea nitrogen (mmol/L) concentrations in peripheral blood.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 May 2015
- Primary completion31 Dec 2023
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Huangan Wu, PhD, MD, Study chair, Shanghai Institute of Acupuncture, Moxibustion and Meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364722
- Sponsor's protocol ID
- ZYS2024-02
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease
- ClinicalTrials.gov ID
- NCT06364722
- Acronym / sponsor ID
- ZYS2024-02
- Conditions
- Crohn Disease
- Keywords
- acupuncture, brain-gut interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupuncture treatmentSubjects in this group will receive real acupuncture combined with real moxibustion. |
| Sham group | Sham comparator | Other: Sham acupunctureSubjects in this group will receive sham acupuncture combined with sham moxibustion. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture treatmentWe 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. | Other | Acupuncture group |
| Sham acupunctureSham 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. | Other | Sham group |
Primary outcome
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.
11 secondary outcomes
Effects of Acupuncture on Anxiety and Depression
Time frame: Week 12
Effects of Acupuncture on Quality of Life
Time frame: Week 12
Effect of acupuncture on intestinal inflammation
Time frame: Week 12
Effects of acupuncture on gut microbiota
Time frame: Week 12
Effects of acupuncture on the functional activity of brain networks
Time frame: Week 12
Effects of acupuncture on intestinal inflammation
Time frame: Week 12
Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations
Time frame: Week 12
Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment)
Time frame: Week 12
Safety evaluation (number of participants with abnormal routine blood tests)
Time frame: Week 12
Safety evaluation (number of participants with abnormal Liver function tests)
Time frame: Week 12
Safety evaluation (number of participants with abnormal Renal function tests)
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huangan Wu, PhD, MD study chair
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture treatment in people with Crohn Disease, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Acupuncture on Crohn's Disease Activity Index (CDAI) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.