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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jun 18, 2018
Open Peer Review Period: Jun 21, 2018 - Aug 5, 2018
Date Accepted: Aug 5, 2018
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

Witges K, Targownik LE, Haviva C, Walker JR, Graff LA, Sexton KA, Lix L, Sargent M, Vagianos K, Bernstein CN

Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

JMIR Res Protoc 2018;7(11):e11317

DOI: 10.2196/11317

PMID: 30425031

PMCID: 6256106

Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

  • Kelcie Witges; 
  • Laura E Targownik; 
  • Clove Haviva; 
  • John R Walker; 
  • Lesley A Graff; 
  • Kathryn A Sexton; 
  • Lisa Lix; 
  • Michael Sargent; 
  • Kathy Vagianos; 
  • Charles N Bernstein

ABSTRACT

Background:

There has been limited longitudinal research that has comprehensively evaluated possible factors in the exacerbation of inflammatory bowel disease (IBD) symptoms with or without associated inflammation. Evolving Web-based technologies facilitate frequent monitoring of patients’ experiences and allow a fine-grained assessment of disease course.

Objective:

We aimed to prospectively identify factors associated with symptom exacerbation and inflammation in IBD including psychological functioning, diet, health behaviors, and medication adherence.

Methods:

Between June 2015 and May 2017, we enrolled adults with IBD, recruited from multiple sources, who had been symptomatically active at least once within the prior 2 years. They completed a Web-based survey every 2 weeks for 1 year and submitted a stool sample at baseline, 26 weeks, and 52 weeks. Any participant reporting a symptom exacerbation was matched to a control within the cohort, based on disease type, sex, age, and time of enrollment; both were sent a supplemental survey and stool collection kit. Biweekly surveys included validated measures of the disease course, psychological functioning, health comorbidities, and medication use. Intestinal inflammation was identified through fecal calprotectin (positive level >250 μg/g stool).

Results:

There were 155 participants enrolled with confirmed IBD, 66.5% (103/155) with Crohn disease and 33.5% (52/155) with ulcerative colitis, of whom 98.7% (153/155) completed the study. Over the 1-year period, 47.7% (74/155) participants experienced a symptom exacerbation. The results of analyses on risk factors for symptom exacerbations are pending.

Conclusions:

We recruited and retained a longitudinal IBD cohort that will allow the determination of risk factors for symptom exacerbation with and without inflammation. This will increase understanding of symptom exacerbations among persons with IBD. International Registered Report Identifier (IRRID): RR1-10.2196/11317


 Citation

Please cite as:

Witges K, Targownik LE, Haviva C, Walker JR, Graff LA, Sexton KA, Lix L, Sargent M, Vagianos K, Bernstein CN

Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

JMIR Res Protoc 2018;7(11):e11317

DOI: 10.2196/11317

PMID: 30425031

PMCID: 6256106

Per the author's request the PDF is not available.

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