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Inflammatory bowel disease(IBD), including ulcerative colitis (UC) and Crohn's disease (CD), is characterized by chronic and recurrent nonspecific intestinal inflammation with high disability rate. During the past few decades, the prevalence of IBD is increasing, especially in developing countries, which brings great burden to patients themselves and medical insurance. Currently, biological medications such as TNFα inhibitors (infliximab, adalimumab, etc.), integrin receptor antagonist (vedolizumab) and interleukin 12/interleukin 23 inhibitor (ustekinumab) are commonly used in IBD treatment as well as traditional drugs such as glucocorticoid, immunosupressive agents and 5-Aminosalicylic Acid, and surgury. However, health-econimic analysis is lacking in Chinese IBD patients and more research is needed for making treatment choice.
Meanwhile, the etiology, disease progression and prognosis prediction has not totally been clarified. The efficacy prediction model of vedolizumab and infliximab has been analyzed, whose prediction markers include level of albumin, smoking, surgery history, fistula, etc. However, no model has included predictors concerning disease pathway or pharmacological pathway in patients accepting different therapy. So a model to predict IBD progression and prognosis concerning pharmacological pathway is going to be explored.
The research is aimed at exploring the mode of IBD progression and predicting prognosis of different IBD patients so that treatment choice could be made to get better efficacy and decrease economic burden of patients and medical insurance. So blood and stool samples before and after treatment are collected to detect changes in gut microbiota and blood proteomics markers and explore the prediction model. Also, inflammatory bowel disease questionnaire (IBDQ) and EQ5D3L will be collected and cost-utility analysis will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC patients | Patients who were diagnosed moderate-to-severe ulcerative colitis (UC) and intend to be treated by biological agents (infliximab or vedolizumab) or traditional drugs (glucocoticoid, immunosupressive drugs and/or mesalazine) will be enrolled. |
| |
| CD patients | Patients who were diagnosed moderate-to-severe Crohn's Disease (CD) and intend to be treated by biological agents (infliximab or ustekinumab) or traditional drugs (glucocoticoid, immunosupressive drugs and/or mesalazine) will be enrolled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | A TNFα inhibitor in UC and CD treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| endoscopic remission rate at week 12 | Endoscopic remission is defined as Mayo endoscopic subscore ≤1. | week 12 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| clinical remission at week 0, 12 and 52 | Clinical remission: defined as a Mayo score ≤2 and no individual subscore >1. | week 0, week 12 and week 52 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| side effect rate at week 0,12 and 52 | side effect includes medication side effects, infection, reactivation of tuberculosis or hepatitis B, cancer, etc. | week 0, week 12 and week 52 after treatment |
Inclusion Criteria:
Exclusion Criteria:
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This is a multicentered research and Chinese patients who meet the eligibility criteria will be enrolled. The medical centers are Peking Union Medical College Hospital, Beijing Chaoyang Hospital, Peking University Third Hospital, Beijing Shijingshan Hospital and the 7th Medical Center of PLA General Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Hong Yang, Doctor | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31504519 | Background | Torabi M, Bernstein CN, Yu BN, Wickramasinghe L, Blanchard JF, Singh H. Geographical Variation and Factors Associated With Inflammatory Bowel Disease in a Central Canadian Province. Inflamm Bowel Dis. 2020 Mar 4;26(4):581-590. doi: 10.1093/ibd/izz168. | |
| 29050646 | Background | Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| C543529 | vedolizumab |
| D000069549 | Ustekinumab |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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Patients' residual blood sample after test and stool specimen are collected.
| Vedolizumab | Drug | An integrin receptor antagonist in UC and CD treatment |
|
|
| Ustekinumab | Drug | An IL-12/IL-23 inhibitor in CD treatment |
|
|
| conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine) | Drug | Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA). |
|
|
| 22435503 | Background | Ouyang Q, Xue LY. Inflammatory bowel disease in the 21(st) century in China: turning challenges into opportunities. J Dig Dis. 2012 Apr;13(4):195-9. doi: 10.1111/j.1751-2980.2012.00579.x. |
| 30177785 | Background | Ng SC, Kaplan GG, Tang W, Banerjee R, Adigopula B, Underwood FE, Tanyingoh D, Wei SC, Lin WC, Lin HH, Li J, Bell S, Niewiadomski O, Kamm MA, Zeng Z, Chen M, Hu P, Ong D, Ooi CJ, Ling KL, Miao Y, Miao J, Janaka de Silva H, Niriella M, Aniwan S, Limsrivilai J, Pisespongsa P, Wu K, Yang H, Ng KK, Yu HH, Wang Y, Ouyang Q, Abdullah M, Simadibrata M, Gunawan J, Hilmi I, Lee Goh K, Cao Q, Sheng H, Ong-Go A, Chong VH, Ching JYL, Wu JCY, Chan FKL, Sung JJY. Population Density and Risk of Inflammatory Bowel Disease: A Prospective Population-Based Study in 13 Countries or Regions in Asia-Pacific. Am J Gastroenterol. 2019 Jan;114(1):107-115. doi: 10.1038/s41395-018-0233-2. |
| 19101844 | Background | Solberg IC, Lygren I, Jahnsen J, Aadland E, Hoie O, Cvancarova M, Bernklev T, Henriksen M, Sauar J, Vatn MH, Moum B; IBSEN Study Group. Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study). Scand J Gastroenterol. 2009;44(4):431-40. doi: 10.1080/00365520802600961. |
| 33183228 | Background | Lv H, Jin M, Zhang H, Chen X, Wu M, Guo M, Zhou R, Wang Z, Yang H, Qian J. Increasing newly diagnosed inflammatory bowel disease and improving prognosis in China: a 30-year retrospective study from a single centre. BMC Gastroenterol. 2020 Nov 12;20(1):377. doi: 10.1186/s12876-020-01527-1. |
| 28973005 | Background | Pillai N, Dusheiko M, Burnand B, Pittet V. A systematic review of cost-effectiveness studies comparing conventional, biological and surgical interventions for inflammatory bowel disease. PLoS One. 2017 Oct 3;12(10):e0185500. doi: 10.1371/journal.pone.0185500. eCollection 2017. |
| 30009158 | Background | Jean L, Audrey M, Beauchemin C, Consortium OBOTI. Economic Evaluations of Treatments for Inflammatory Bowel Diseases: A Literature Review. Can J Gastroenterol Hepatol. 2018 Jun 13;2018:7439730. doi: 10.1155/2018/7439730. eCollection 2018. |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |