Crohn DiseaseNCT06352164
Efficacy Classification Prediction of the Effects of Acupuncture on Abdominal Pain in Patients With Crohn's Disease
A study testing Acupuncture treatment in people with Crohn Disease, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
Machine learning algorithms are applied to discover gut flora markers that predict the clinical efficacy of acupuncture, so as to screen the appropriate population for acupuncture and optimise the allocation of healthcare resources. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Acupuncture treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2015to 31 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-75, no gender limit;
- disease in mild and moderate active period: 150≤CDAI<450 and meet at least one of the following: Serum C-reactive protein level≥5mg/L, Fecal calprotectin concentration≥250μg/g or endoscopic examination shows ulcers. remission period: CDAI <150 and meet at least one of the following: Serum C-reactive protein level<5 mg/L, Fecal calprotectin concentration <250μg/g or endoscopic examination shows no ulcer;
- patients were not taking medication or were only taking one or more of the following drugs: mesalazine (≤4g/d and mesalazine was used for at least 1 month), prednisone (≤15mg/d and prednisone was used for at least 1 month) and / or azathioprine (≤1mg/kg/d and azathioprine was used for at least 3 month);
- those who have not used biologics within 3 months before entering the study;
- those who have never experienced acupuncture;
- those who understand and agree to participate in this study and sign the informed consent form.
Who cannot join
- patients who are recently pregnant or in pregnancy or lactation;
- patients with serious organic diseases;
- patients diagnosed as psychosis;
- patients 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Shanghai, 200000
About this study
Official title: Predicting the Clinical Efficacy of Acupuncture for Abdominal Pain in Patients With Crohn's Disease Based on Gut Microbiology and Machine Learning
Machine learning algorithms are applied to discover gut flora markers that predict the clinical efficacy of acupuncture, so as to screen the appropriate population for acupuncture and optimise the allocation of healthcare resources.
Read the detailed description
Crohn's disease is an intestinal inflammatory disease,causing abdominal pain, diarrhea and other symptoms.The intestinal flora disorder is closely related to the occurrence and development of Crohn's disease. Acupuncture can induce remission of Crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. Acupuncture can affect the gut microbiota. The aim of this study was to apply gut microbiological data and clinical data from subjects at baseline to predict the clinical efficacy of acupuncture by machine learning algorithms, and to classify patients as effective/ineffective in order to screen for suitable subjects for acupuncture.
- Conditions
- Crohn Disease
- Being tested
- Acupuncture treatment
- Keywords
- Crohn Disease, Intestinal flora, Abdominal pain, Machine learning
- Medical subject headings
- Crohn Disease, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture treatmentOther
The investigators 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) 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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Subjects receiving acupuncture and moxibustion treatment. Receives: Other: Acupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of gut microflora strains predictive of acupuncture efficacy
Application of machine learning algorithms to discover gut microbial markers (Characterisation of intestinal flora strains) predicting clinical efficacy of acupuncture to screen for appropriate acupuncture populations.
Criteria for judging the efficacy of acupuncture: At 12 weeks, patients had complete remission of abdominal pain ( VAS score or frequency of abdominal pain per week = 0) or remission of abdominal pain ( the reduction of VAS score or the frequency of abdominal pain ≥ 3 compare with baseline) were considered effective. Otherwise, it was considered ineffective.
Visual Analogue Scale(VAS score):The maximum score is 0, and the minimum score is 10.Higher scores represent a greater degree of abdominal pain and higher scores mean a worse outcome.
Frequency of abdominal pain：The maximum score is 0, and the minimum score is 7. Higher scores represent a greater degree of abdominal pain and higher scores mean a worse outcome.
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 posted8 Apr 2024
- Study start1 Mar 2015
- Primary completion31 Dec 2023
- Study completion31 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu Huangan, PhD,MD, Study chair, Shanghai Institute of Acupuncture, Moxibustion and Meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352164
- Sponsor's protocol ID
- ZYS2024-03
- Status last verified
- Mar 2024
- First submitted
- 2 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Clinical Efficacy of Acupuncture for Abdominal Pain in Patients With Crohn's Disease Based on Gut Microbiology and Machine Learning
- ClinicalTrials.gov ID
- NCT06352164
- Acronym / sponsor ID
- ZYS2024-03
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Intestinal flora, Abdominal pain, Machine learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 8 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.
Machine learning algorithms are applied to discover gut flora markers that predict the clinical efficacy of acupuncture, so as to screen the appropriate population for acupuncture and optimise the allocation of healthcare resources.
Detailed description
Crohn's disease is an intestinal inflammatory disease,causing abdominal pain, diarrhea and other symptoms.The intestinal flora disorder is closely related to the occurrence and development of Crohn's disease. Acupuncture can induce remission of Crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. Acupuncture can affect the gut microbiota. The aim of this study was to apply gut microbiological data and clinical data from subjects at baseline to predict the clinical efficacy of acupuncture by machine learning algorithms, and to classify patients as effective/ineffective in order to screen for suitable subjects for acupuncture.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupuncture treatmentSubjects receiving acupuncture and moxibustion treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18-75, no gender limit;
- disease in mild and moderate active period: 150≤CDAI<450 and meet at least one of the following: Serum C-reactive protein level≥5mg/L, Fecal calprotectin concentration≥250μg/g or endoscopic examination shows ulcers. remission period: CDAI <150 and meet at least one of the following: Serum C-reactive protein level<5 mg/L, Fecal calprotectin concentration <250μg/g or endoscopic examination shows no ulcer;
- patients were not taking medication or were only taking one or more of the following drugs: mesalazine (≤4g/d and mesalazine was used for at least 1 month), prednisone (≤15mg/d and prednisone was used for at least 1 month) and / or azathioprine (≤1mg/kg/d and azathioprine was used for at least 3 month);
- those who have not used biologics within 3 months before entering the study;
- those who have never experienced acupuncture;
Key exclusion criteria (8 listed)
- patients who are recently pregnant or in pregnancy or lactation;
- patients with serious organic diseases;
- patients diagnosed as psychosis;
- patients 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;
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 treatmentThe investigators 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) 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 |
Primary outcome
Characterisation of gut microflora strains predictive of acupuncture efficacy
Time frame: Week 12
Application of machine learning algorithms to discover gut microbial markers (Characterisation of intestinal flora strains) predicting clinical efficacy of acupuncture to screen for appropriate acupuncture populations. Criteria for judging the efficacy of acupuncture: At 12 weeks, patients had complete remission of abdominal pain ( VAS score or frequency of abdominal pain per week = 0) or remission of abdominal pain ( the reduction of VAS score or the frequency of abdominal pain ≥ 3 compare with baseline) were considered effective. Otherwise, it was considered ineffective. Visual Analogue Scale(VAS score):The maximum score is 0, and the minimum score is 10.Higher scores represent a greater degree of abdominal pain and higher scores mean a worse outcome. Frequency of abdominal pain：The maximum score is 0, and the minimum score is 7. Higher scores represent a greater degree of abdominal pain and higher scores mean a worse outcome.
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 9 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.
Wu Huangan, PhD,MD study chair
Shanghai Institute of Acupuncture, Moxibustion and Meridian
1 site in 1 country: see every site and its status.
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 at 1 site in China.
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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Characterisation of gut microflora strains predictive of acupuncture efficacy (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 9 Apr 2024.