Acupuncture Treatment for Active Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

Effect of Acupuncture on Maintaining Active Crohn's Disease Intestinal Homeostasis Via Intestinal Microbiota and Peripheral Immunity: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559037
• Other study ID #: ZYS2015-02
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.

Description:

1. A randomized controlled trial.

2. Acupuncture and moxibustion treatment, placebo control.

3. To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease.

4. To observe the effect on the regulation of intestinal microbiota in Crohn's disease.

5. To observe the effect on the regulation of peripheral immunity in Crohn's disease.

6. To observe the effect on the regulation of brain function and structure in Crohn's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

1. meet the diagnostic criteria of Crohn's disease;

2. age 16-70 years old;

3. patients with mild or moderate disease (150<CDAI<450) and evidence of active inflammation: serum C-reactive protein concentration =5 mg/L, fecal calprotectin concentration =250 µg/g, or obvious endoscopic evidence of ulcerations during the screening period of past 4 weeks;

4. patients who were not responsive, intolerant, dependent, or refused to use any one of the following medications: mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), and anti-TNF-a agents;

5. did not take or take one or more of the following drugs: prednisone <15 mg/d for at least one month, azathioprine (<1 mg/kg/d), methotrexate (<15 mg/week), or mesalazine (<4 g/d) for at least 3 months;

6. no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;

7. no previous history of receiving acupuncture;

8. provision of written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, and those desirous of conceiving in the near future;

2. patients with severe organic diseases;

3. patients with mental illness;

4. patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;

5. patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;

6. patients with severe extraintestinal manifestations, such as severe skin diseases, eye diseases, or thromboembolic diseases;

7. severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal abscess, gastrointestinal bleeding, bowel perforation, or other complications;

8. patients with short bowel syndrome;

9. patients with a history of abdominal or gastrointestinal surgery in the past six months;

10. patients with skin diseases or defects at the sites of acupuncture that prevents the application of acupuncture.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Device:
• Acupuncture and moxibustion
Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30*40mm or 0.30*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min. Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ? ± 1 ?, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48.
• Sham acupuncture and moxibustion
The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 * 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation. Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ? ± 1 ?, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48.

Locations

Country	Name	City	State
China	Shanghai Institute of Acupuncture, Moxibustion and Meridian	Shanghai	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian	Changhai Hospital, Fudan University, Indiana University School of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intestinal microbiota	Fecal microbiota structure and diversity	Week 12
Other	Plasma inflammatory cytokine levels	IFN-?, TNF-a, IL-1ß IL-17,IL-23 etc.	Week 12
Other	Intestinal barrier function	Plasma Diamine oxidase,lipopolysaccharide, D-lactate level	Week 12
Other	Brain functional changes	Using fMRI (resting-state fMRI)	Week 12
Other	Brain structural changes	brain gray matter, white matter changes	Week 12
Other	Correlation analysis of the change of CRP level and intestinal flora and plasma inflammatory levels at the end of acupuncture treatment	To explore the relationship between CRP and intestinal flora and inflammation influenced by acupuncture	Week 12
Other	Correlation analysis of the change of CRP level and and brain structure and function	To explore the relationship between intestinal inflammation and brain function influenced by acupuncture	Week 12
Other	Correlation analysis of intestinal flora and brain structure and function	To explore the relationship between intestinal flora and brain-gut axis	Week 12
Primary	The proportion of patients with clinical remission	Defined as Crohn's disease activity Index (CDAI) < 150 and decrease > 70	Week 12
Secondary	The proportion of patients with clinical remission	Defined as CDAI < 150 and decrease > 70	Week 24, 36 and 48
Secondary	The proportion of patients with clinical response	Defined as CDAI decrease > 70	Week 12, 24, 36 and 48
Secondary	the mean change of CDAI from baseline	Difference in the mean change of CDAI from baseline between groups	Week 12, 24, 36 and 48
Secondary	Laboratory tests for disease activity	C-reaction protein, mg/L	Week 12, 24, 36 and 48
Secondary	Laboratory tests for disease activity	Erythrocyte sedimentation rate, mm/h	Week 12, 24, 36 and 48
Secondary	Laboratory tests for disease activity	blood platelet level, L	Week 12, 24, 36 and 48
Secondary	Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ)	QOL assessment for Crohn's disease	Week 12 and 24
Secondary	Psychological factors on the Hospital anxiety and depression scale (HADS)	Anxiety and depression assessment for CD	Week 12 and 24
Secondary	The mean change of Crohn's disease endoscopic index of severity (CDEIS)	Intestinal inflammation performance	Week 48
Secondary	Fecal calprotectin tests for disease activity	Intestinal inflammation assessment	Week 12
Secondary	Histological scores for pathogenic manifestations	Hematoxylin-eosin staining and Histological scores	Week 48
Secondary	The proportion of clinical recurrences	Defined as CDAI > 150 and increased by =70 points or need to adjust drug to control active disease	Week 24,36 and 48
Secondary	Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)	Eg. acupuncture related bleeding, hematoma, fainting needle, etc; moxibustion related burns, blistering, etc	Week 12, 24,36 and 48
Secondary	Subgroup analysis of the main outcome measure	Compare using chi square test with stratified method or Fisher's exact test, and Gender, BMI, CDAI score at baseline, concomitant medicine, Montreal classification, biologic use history, and surgical history were used as stratification factors.	Week 12