Clinical trial NCT06352164: Efficacy Classification Prediction of the Effects of Acupuncture on Abdominal Pain in Patients With Crohn's Disease
Official title: Predicting the Clinical Efficacy of Acupuncture for Abdominal Pain in Patients With Crohn's Disease Based on Gut Microbiology and Machine Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn Disease
Intestinal flora
Abdominal pain
Machine learning
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. aged 18-75, no gender limit;
2. 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;
3. 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);
4. those who have not used biologics within 3 months before entering the study;
5. those who have never experienced acupuncture;
6. those who understand and agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. patients who are recently pregnant or in pregnancy or lactation;
2. patients with serious organic diseases;
3. patients diagnosed as psychosis;
4. 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;
5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Primary outcomes:
measure: Characterisation of gut microflora strains predictive of acupuncture efficacy
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Study officials:
affiliation: Shanghai Institute of Acupuncture, Moxibustion and Meridian
name: Wu Huangan, PhD,MD
role: STUDY_CHAIR
References: