Manitoba Inflammatory Bowel Disease Cohort Study

Ulcerative Colitis Clinical Trial

Official title:

Manitoba Inflammatory Bowel Disease Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262649
• Other study ID #: REB#=HS14734 (H2002:040)
• Status: Completed
• Phase: N/A
• First received: August 14, 2017
• Last updated: August 23, 2017
• Start date: March 1, 2002
• Est. completion date: October 1, 2016

Study information

• Verified date: August 2017
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study participants were drawn from a population-based research registry.

The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys and annually with interviews. Diagnosis and disease type were verified by chart review.

Description:

The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study, initiated in 2002, is study of adults with IBD who have been tracked prospectively through annual clinical interviews and semiannual surveys. The participants were drawn from a validated population-based research registry, which identified and recruited individuals using an administrative definition of IBD from the comprehensive health data base of Manitoba Health, the single insurer that provides health care to all residents in the province.

The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys and annually with interviews. Diagnosis and disease type were verified by chart review. It has been demonstrated that the Cohort is representative of the provincial IBD population as a whole, with comparable age distribution, sex distribution, disease duration, and rural/urban residence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: October 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• diagnosed within the previous 7 years with Inflammatory Bowel Disease

Exclusion Criteria:

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

References & Publications (59)

Amir Shaghaghi M, Bernstein CN, Serrano León A, El-Gabalawy H, Eck P. Polymorphisms in the sodium-dependent ascorbate transporter gene SLC23A1 are associated with susceptibility to Crohn disease. Am J Clin Nutr. 2014 Feb;99(2):378-83. doi: 10.3945/ajcn.11 — View Citation

Benchimol EI, Bernstein CN, Bitton A, Carroll MW, Singh H, Otley AR, Vutcovici M, El-Matary W, Nguyen GC, Griffiths AM, Mack DR, Jacobson K, Mojaverian N, Tanyingoh D, Cui Y, Nugent ZJ, Coulombe J, Targownik LE, Jones JL, Leddin D, Murthy SK, Kaplan GG. T — View Citation

Benchimol EI, Kaplan GG, Otley AR, Nguyen GC, Underwood FE, Guttmann A, Jones JL, Potter BK, Catley CA, Nugent ZJ, Cui Y, Tanyingoh D, Mojaverian N, Bitton A, Carroll MW, deBruyn J, Dummer TJB, El-Matary W, Griffiths AM, Jacobson K, Kuenzig ME, Leddin D, — View Citation

Bernstein CN, Bector S, Leslie WD. Lack of relationship of calcium and vitamin D intake to bone mineral density in premenopausal women with inflammatory bowel disease. Am J Gastroenterol. 2003 Nov;98(11):2468-73. — View Citation

Bernstein CN, Blanchard JF, Houston DS, Wajda A. The incidence of deep venous thrombosis and pulmonary embolism among patients with inflammatory bowel disease: a population-based cohort study. Thromb Haemost. 2001 Mar;85(3):430-4. — View Citation

Bernstein CN, Blanchard JF, Leslie W, Wajda A, Yu BN. The incidence of fracture among patients with inflammatory bowel disease. A population-based cohort study. Ann Intern Med. 2000 Nov 21;133(10):795-9. — View Citation

Bernstein CN, Blanchard JF, Rawsthorne P, Yu N. The prevalence of extraintestinal diseases in inflammatory bowel disease: a population-based study. Am J Gastroenterol. 2001 Apr;96(4):1116-22. — View Citation

Bernstein CN, El-Gabalawy H, Sargent M, Landers C, Rawsthorne P, Elias B, Targan SR. Assessing inflammatory bowel disease-associated antibodies in Caucasian and First Nations cohorts. Can J Gastroenterol. 2011 May;25(5):269-73. — View Citation

Bernstein CN, Garland A, Peschken CA, Hitchon CA, Chen H, Fransoo R, Marrie RA. Predictors of ICU Admission and Outcomes 1 Year Post-Admission in Persons with IBD: A Population-based Study. Inflamm Bowel Dis. 2015 Jun;21(6):1341-7. doi: 10.1097/MIB.000000 — View Citation

Bernstein CN, Leslie WD, Taback SP. Bone density in a population-based cohort of premenopausal adult women with early onset inflammatory bowel disease. Am J Gastroenterol. 2003 May;98(5):1094-100. — View Citation

Bernstein CN, Ng SC, Lakatos PL, Moum B, Loftus EV Jr; Epidemiology and Natural History Task Force of the International Organization of the Study of Inflammatory Bowel Disease. A review of mortality and surgery in ulcerative colitis: milestones of the ser — View Citation

Bernstein CN, Nugent Z, Blanchard JF. 5-aminosalicylate is not chemoprophylactic for colorectal cancer in IBD: a population based study. Am J Gastroenterol. 2011 Apr;106(4):731-6. doi: 10.1038/ajg.2011.50. Epub 2011 Mar 15. — View Citation

Bernstein CN, Ryan JD, Graff LA, Xu W. Commentary: predicting complicated Crohn's disease and surgery--phenotypes, genetics, serology and psychological characteristics of a population-based cohort--authors' reply. Aliment Pharmacol Ther. 2013 Sep;38(5):55 — View Citation

Bernstein CN, Wajda A, Blanchard JF. The clustering of other chronic inflammatory diseases in inflammatory bowel disease: a population-based study. Gastroenterology. 2005 Sep;129(3):827-36. — View Citation

Bernstein CN, Wajda A, Blanchard JF. The incidence of arterial thromboembolic diseases in inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2008 Jan;6(1):41-5. Epub 2007 Dec 11. — View Citation

Bernstein MT, Graff LA, Targownik LE, Downing K, Shafer LA, Rawsthorne P, Bernstein CN, Avery L. Gastrointestinal symptoms before and during menses in women with IBD. Aliment Pharmacol Ther. 2012 Jul;36(2):135-44. doi: 10.1111/j.1365-2036.2012.05155.x. Ep — View Citation

Brant SR, Wang MH, Rawsthorne P, Sargent M, Datta LW, Nouvet F, Shugart YY, Bernstein CN. A population-based case-control study of CARD15 and other risk factors in Crohn's disease and ulcerative colitis. Am J Gastroenterol. 2007 Feb;102(2):313-23. Epub 20 — View Citation

Burgmann T, Clara I, Graff L, Walker J, Lix L, Rawsthorne P, McPhail C, Rogala L, Miller N, Bernstein CN. The Manitoba Inflammatory Bowel Disease Cohort Study: prolonged symptoms before diagnosis--how much is irritable bowel syndrome? Clin Gastroenterol H — View Citation

Clara I, Lix LM, Walker JR, Graff LA, Miller N, Rogala L, Rawsthorne P, Bernstein CN. The Manitoba IBD Index: evidence for a new and simple indicator of IBD activity. Am J Gastroenterol. 2009 Jul;104(7):1754-63. doi: 10.1038/ajg.2009.197. Epub 2009 May 19 — View Citation

Ediger JP, Walker JR, Graff L, Lix L, Clara I, Rawsthorne P, Rogala L, Miller N, McPhail C, Deering K, Bernstein CN. Predictors of medication adherence in inflammatory bowel disease. Am J Gastroenterol. 2007 Jul;102(7):1417-26. Epub 2007 Apr 16. — View Citation

El-Matary W, Abej E, Deora V, Singh H, Bernstein CN. Impact of Fecal Calprotectin Measurement on Decision-making in Children with Inflammatory Bowel Disease. Front Pediatr. 2017 Jan 25;5:7. doi: 10.3389/fped.2017.00007. eCollection 2017. — View Citation

Goldenberg BA, Graff LA, Clara I, Zarychanski R, Walker JR, Carr R, Rogala L, Miller N, Bernstein CN. Is iron deficiency in the absence of anemia associated with fatigue in inflammatory bowel disease? Am J Gastroenterol. 2013 Sep;108(9):1392-7. doi: 10.10 — View Citation

Goldenberg BA, Rawsthorne P, Bernstein CN. The utility of 6-thioguanine metabolite levels in managing patients with inflammatory bowel disease. Am J Gastroenterol. 2004 Sep;99(9):1744-8. — View Citation

Graff LA, Clara I, Walker JR, Lix L, Carr R, Miller N, Rogala L, Bernstein CN. Changes in fatigue over 2 years are associated with activity of inflammatory bowel disease and psychological factors. Clin Gastroenterol Hepatol. 2013 Sep;11(9):1140-6. doi: 10 — View Citation

Graff LA, Sexton KA, Walker JR, Clara I, Targownik LE, Bernstein CN. Validating a Measure of Patient Self-efficacy in Disease Self-management Using a Population-based IBD Cohort: The IBD Self-efficacy Scale. Inflamm Bowel Dis. 2016 Sep;22(9):2165-72. doi: — View Citation

Graff LA, Vincent N, Walker JR, Clara I, Carr R, Ediger J, Miller N, Rogala L, Rawsthorne P, Lix L, Bernstein CN. A population-based study of fatigue and sleep difficulties in inflammatory bowel disease. Inflamm Bowel Dis. 2011 Sep;17(9):1882-9. doi: 10.1 — View Citation

Graff LA, Walker JR, Clara I, Lix L, Miller N, Rogala L, Rawsthorne P, Bernstein CN. Stress coping, distress, and health perceptions in inflammatory bowel disease and community controls. Am J Gastroenterol. 2009 Dec;104(12):2959-69. doi: 10.1038/ajg.2009. — View Citation

Graff LA, Walker JR, Lix L, Clara I, Rawsthorne P, Rogala L, Miller N, Jakul L, McPhail C, Ediger J, Bernstein CN. The relationship of inflammatory bowel disease type and activity to psychological functioning and quality of life. Clin Gastroenterol Hepato — View Citation

Israeli E, Graff LA, Clara I, Walker JR, Lix LM, Targownik LE, Bernstein CN. Low prevalence of disability among patients with inflammatory bowel diseases a decade after diagnosis. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1330-7.e2. doi: 10.1016/j.cgh.20 — View Citation

Jewel Samadder N, Valentine JF, Guthery S, Singh H, Bernstein CN, Wan Y, Wong J, Boucher K, Pappas L, Rowe K, Bronner M, Ulrich CM, Burt RW, Curtin K, Smith KR. Colorectal Cancer in Inflammatory Bowel Diseases: A Population-Based Study in Utah. Dig Dis Sc — View Citation

Leslie WD, Miller N, Rogala L, Bernstein CN. Body mass and composition affect bone density in recently diagnosed inflammatory bowel disease: the Manitoba IBD Cohort Study. Inflamm Bowel Dis. 2009 Jan;15(1):39-46. doi: 10.1002/ibd.20541. — View Citation

Leslie WD, Miller N, Rogala L, Bernstein CN. Vitamin D status and bone density in recently diagnosed inflammatory bowel disease: the Manitoba IBD Cohort Study. Am J Gastroenterol. 2008 Jun;103(6):1451-9. doi: 10.1111/j.1572-0241.2007.01753.x. Epub 2008 Ap — View Citation

Lix LM, Graff LA, Walker JR, Clara I, Rawsthorne P, Rogala L, Miller N, Ediger J, Pretorius T, Bernstein CN. Longitudinal study of quality of life and psychological functioning for active, fluctuating, and inactive disease patterns in inflammatory bowel d — View Citation

Longobardi T, Bernstein CN. Health care resource utilization in inflammatory bowel disease. Clin Gastroenterol Hepatol. 2006 Jun;4(6):731-43. Epub 2006 May 2. — View Citation

Longobardi T, Walker JR, Graff LA, Bernstein CN. Health service utilization in IBD: comparison of self-report and administrative data. BMC Health Serv Res. 2011 May 31;11:137. doi: 10.1186/1472-6963-11-137. — View Citation

Marrie RA, Garland A, Peschken CA, Hitchon CA, Chen H, Fransoo R, Bernstein CN. Increased incidence of critical illness among patients with inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2063-70.e1-4. doi — View Citation

Marrie RA, Sellers EAC, Chen H, Fransoo R, Bernstein CN, Hitchon CA, Peschken CA, Garland A. Markedly increased incidence of critical illness in adults with Type 1 diabetes. Diabet Med. 2017 Jun 19. doi: 10.1111/dme.13404. [Epub ahead of print] — View Citation

Marrie RA, Walker JR, Graff LA, Lix LM, Bolton JM, Nugent Z, Targownik LE, Bernstein CN; CIHR Team “Defining the burden and managing the effects of psychiatric comorbidity in chronic immunoinflammatory disease”. Performance of administrative case definiti — View Citation

Nguyen GC, Bernstein CN, Benchimol EI. Risk of Surgery and Mortality in Elderly-onset Inflammatory Bowel Disease: A Population-based Cohort Study. Inflamm Bowel Dis. 2017 Feb;23(2):218-223. doi: 10.1097/MIB.0000000000000993. — View Citation

Nguyen GC, Nugent Z, Shaw S, Bernstein CN. Outcomes of patients with Crohn's disease improved from 1988 to 2008 and were associated with increased specialist care. Gastroenterology. 2011 Jul;141(1):90-7. doi: 10.1053/j.gastro.2011.03.050. Epub 2011 Mar 31 — View Citation

Nugent Z, Blanchard JF, Bernstein CN. A population-based study of health-care resource use among infliximab users. Am J Gastroenterol. 2010 Sep;105(9):2009-16. doi: 10.1038/ajg.2010.139. Epub 2010 Apr 6. — View Citation

Okazaki T, Wang MH, Rawsthorne P, Sargent M, Datta LW, Shugart YY, Bernstein CN, Brant SR. Contributions of IBD5, IL23R, ATG16L1, and NOD2 to Crohn's disease risk in a population-based case-control study: evidence of gene-gene interactions. Inflamm Bowel — View Citation

Rawsthorne P, Clara I, Graff LA, Bernstein KI, Carr R, Walker JR, Ediger J, Rogala L, Miller N, Bernstein CN. The Manitoba Inflammatory Bowel Disease Cohort Study: a prospective longitudinal evaluation of the use of complementary and alternative medicine — View Citation

Restall GJ, Simms AM, Walker JR, Graff LA, Sexton KA, Rogala L, Miller N, Haviva C, Targownik LE, Bernstein CN. Understanding Work Experiences of People with Inflammatory Bowel Disease. Inflamm Bowel Dis. 2016 Jul;22(7):1688-97. doi: 10.1097/MIB.000000000 — View Citation

Restall GJ, Simms AM, Walker JR, Haviva C, Graff LA, Sexton KA, Miller N, Targownik LE, Bernstein CN. Coping with Inflammatory Bowel Disease: Engaging with Information to Inform Health-Related Decision Making in Daily Life. Inflamm Bowel Dis. 2017 Aug;23( — View Citation

Rogala L, Miller N, Graff LA, Rawsthorne P, Clara I, Walker JR, Lix L, Ediger JP, McPhail C, Bernstein CN. Population-based controlled study of social support, self-perceived stress, activity and work issues, and access to health care in inflammatory bowe — View Citation

Ryan JD, Silverberg MS, Xu W, Graff LA, Targownik LE, Walker JR, Carr R, Clara I, Miller N, Rogala L, Bernstein CN. Predicting complicated Crohn's disease and surgery: phenotypes, genetics, serology and psychological characteristics of a population-based — View Citation

Sajobi TT, Lix LM, Clara I, Walker J, Graff LA, Rawsthorne P, Miller N, Rogala L, Carr R, Bernstein CN. Measures of relative importance for health-related quality of life. Qual Life Res. 2012 Feb;21(1):1-11. doi: 10.1007/s11136-011-9914-7. Epub 2011 Apr 2 — View Citation

Serrano León A, Amir Shaghaghi M, Yurkova N, Bernstein CN, El-Gabalawy H, Eck P. Single-nucleotide polymorphisms in SLC22A23 are associated with ulcerative colitis in a Canadian white cohort. Am J Clin Nutr. 2014 Jul;100(1):289-94. doi: 10.3945/ajcn.113.0 — View Citation

Shaw SY, Blanchard JF, Bernstein CN. Association between the use of antibiotics and new diagnoses of Crohn's disease and ulcerative colitis. Am J Gastroenterol. 2011 Dec;106(12):2133-42. doi: 10.1038/ajg.2011.304. Epub 2011 Sep 13. — View Citation

Singh H, Nugent Z, Demers AA, Kliewer EV, Mahmud SM, Bernstein CN. The reduction in colorectal cancer mortality after colonoscopy varies by site of the cancer. Gastroenterology. 2010 Oct;139(4):1128-37. doi: 10.1053/j.gastro.2010.06.052. Epub 2010 Jun 20. — View Citation

Singh H, Nugent Z, Yu BN, Lix LM, Targownik LE, Bernstein CN. Higher Incidence of Clostridium difficile Infection Among Individuals With Inflammatory Bowel Disease. Gastroenterology. 2017 Aug;153(2):430-438.e2. doi: 10.1053/j.gastro.2017.04.044. Epub 2017 — View Citation

Singh S, Graff LA, Bernstein CN. Do NSAIDs, antibiotics, infections, or stress trigger flares in IBD? Am J Gastroenterol. 2009 May;104(5):1298-313; quiz 1314. doi: 10.1038/ajg.2009.15. Epub 2009 Mar 31. Review. — View Citation

Stainier DY, Bilder DH, Gilbert W. Spatial domains in the developing forebrain: developmental regulation of a restricted cell surface protein. Dev Biol. 1991 Sep;147(1):22-31. — View Citation

Tang LY, Rawsthorne P, Bernstein CN. Are perineal and luminal fistulas associated in Crohn's disease? A population-based study. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1130-4. Epub 2006 Aug 14. — View Citation

Targownik LE, Leslie WD, Carr R, Clara I, Miller N, Rogala L, Graff LA, Walker JR, Bernstein CN. Longitudinal change in bone mineral density in a population-based cohort of patients with inflammatory bowel disease. Calcif Tissue Int. 2012 Nov;91(5):356-63 — View Citation

Targownik LE, Singh H, Nugent Z, Bernstein CN. The epidemiology of colectomy in ulcerative colitis: results from a population-based cohort. Am J Gastroenterol. 2012 Aug;107(8):1228-35. doi: 10.1038/ajg.2012.127. Epub 2012 May 22. Erratum in: Am J Gastroen — View Citation

Vagianos K, Clara I, Carr R, Graff LA, Walker JR, Targownik LE, Lix LM, Rogala L, Miller N, Bernstein CN. What Are Adults With Inflammatory Bowel Disease (IBD) Eating? A Closer Look at the Dietary Habits of a Population-Based Canadian IBD Cohort. JPEN J P — View Citation

Wong S, Walker JR, Carr R, Graff LA, Clara I, Promislow S, Rogala L, Miller N, Rawsthorne P, Bernstein CN. The information needs and preferences of persons with longstanding inflammatory bowel disease. Can J Gastroenterol. 2012 Aug;26(8):525-31. — View Citation

* Note: There are 59 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic Associations	Single Nucleotide Variations (SNPs) in gene encoding for membrane transporter proteins were investigated for associations with both IBDs. Target genes included SLC23A1, SLC22A4, SLC22A5, SLC22A23, SLC2A14, SLC2A2 but analyses are not limited to these.	2010 to 2016
Secondary	Psychological Functioning 1	The validated 7-item Mastery scale assesses the degree to which persons feel they have some control or mastery over their life to handle day-to-day challenges.	2010-2014
Secondary	Self Efficacy	The IBD- Self Efficacy (SE) is a 29-item scale developed by Keefer et al. (1) based on patient interview, validated self-efficacy measures for other diseases. The instrument assesses the level of confidence in managing various disease-related "tasks," with item scores ranging from 1 (not at all) to 10 (totally), and higher scores reflecting greater disease self-management efficacy. Items were grouped conceptually into 4 subscales, reflecting domains identified by patients with IBD as important [1] managing stress and emotions (sample items: keep from feeling sad; do something to reduce stress); [2] managing medical care (sample items: take medication at instructed times; work out differences with doctors); [3] managing symptoms and disease (sample items: keep diarrhea/urgency from interfering; decrease fatigue); [4] maintaining remission (sample items: engage in self-care; maintain sense of well-being).	2010-2014
Secondary	Disability	The Sheehan Disability Scale is a commonly used and validated instrument that measures disease interference in 3 primary domains of life: work, social, and home, based on a visual analog scale from 0 (no interference) to 10 (very severe interference). (1,2); Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11(suppl 3):89-95.; Leon AC, Olfson M, Portera L, et al. Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. Int J Psychiatry Med. 1997;27:93-105.	2010-2014
Secondary	Health and Quality of Life 1	Perceived health was assessed using the General Health item from the Medical Outcome Survey Short Form 36, (1) which asks participants to characterize their health in the past year, using 5 response categories from "Excellent" to "Poor."	2010-2014
Secondary	Disease Activity 1	Current disease activity was assessed using standardized clinical indices, the Harvey-Bradshaw index for CD.	2010-2014
Secondary	Disease Activity 2	Current disease activity was assessed using standardized clinical indices, the modified Powell-Tuck index for UC.	2010-2014
Secondary	Disease Activity 3	Recent disease activity was measured with the Manitoba IBD Index	2010-2014
Secondary	Psychological Functioning 2	The Cohen Perceived Stress Scale is a 14-item questionnaire, with a 5-point Likert response format, that assesses the individual's appraisal of their stress "load" related to chronic and acute stressors.	2010-2014
Secondary	Psychological Functioning 3	The Brief Symptom Inventory is a well-established measure of current emotional distress related to multiple psychological symptoms, consisting of 53 items.	2010-2014
Secondary	Psychological Functioning 4	The Psychological Well-being Manifestations Scale consists of 25 items that query 6 general domains of positive experience using a 5-point Likert frequency scale, with higher scores indicating a greater sense of well-being.	2010-2014
Secondary	Health and Quality of Life 2	The 32-item Inflammatory Bowel Disease Questionnaire is a validated measure that has been extensively used in IBD studies to assess disease-specific quality of life.	2010-2014