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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. This study is to screen the intestinal bacteria related to abdominal pain in CD, and explore the effects of acupuncture on the intestinal flora related to abdominal pain in CD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupuncture group | Experimental | Receiving acupuncture and moxibustion |
|
| sham acupuncture group | Sham Comparator | Receiving sham acupuncture and sham moxibustion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain remission rate | The abdominal pain relief rate is the ratio of the number of subjects with abdominal pain relief at the end of 12 weeks of treatment to the total number of subjects. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Crohn's disease activity index (CDAI) | Between-group assessment by difference in Crohn's Disease Activity Index (CDAI) at 12 weeks from baseline. The minimum value is 0 and there is no upper limit. 0-150: disease in remission; 151-220: mild active disease; 221-450: moderate active disease; values above 450: severe active disease. Higher scores mean a worse outcome. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota composition structure and function | Differences in the compositional structure and function of the intestinal flora in CD patients with abdominal pain before and after 12 weeks of acupuncture treatment. | Week 12 |
| Correlation between changes in relative abundance of gut microbes and abdominal pain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huangan Wu, PhD, MD | Shanghai Institute of Acupuncture, Moxibustion and Meridian | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Institute of Acupuncture, Moxibustion and Meridian | Shanghai | 200000 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Sham acupuncture | Other | 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. |
|
| Hospital anxiety and depression scale (HADS) | Difference in Hospital anxiety and depression scale (HADS) scores from baseline at 12 weeks was used for between-group assessment. The minimum score is 0, and the maximum score is 21. Higher scores mean a worse outcome. | Week 12 |
| Inflammatory bowel disease questionnaire (IBDQ) | Differences in Inflammatory Bowel Disease Questionnaire (IBDQ) scores from baseline at 12 weeks were used for between-group assessment. The minimum score is 32, and the maximum score is 224. Higher scores mean a better outcome. | 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. | 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). | 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. | Week 12 |
Correlation between the relative abundance data of intestinal microbiota which analyzed by metagenomics at different taxonomic levels, such as Phylum,Class,Order,Family, and changes in of abdominal pain VAS score before and after 12 weeks of acupuncture treatment. |
| Week 12 |
| D007410 | Intestinal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |