Hormonal Contraceptives Reduce Active Symptomatic Disease but May Increase Intestinal Inflammation in IBD.

BACKGROUND: Among women of reproductive age with inflammatory bowel disease (IBD), we aimed to assess the relationship of hormonal contraceptives (HCs) with IBD-related symptoms, and intestinal inflammation. METHODS: A nested cohort of women in the longitudinal Manitoba Living with IBD Study, ages 18 to 49, were followed for 1 year, with bi-weekly online surveys. This included a validated measure of disease activity; IBD Symptom Inventory (IBDSI), and stool samples obtained at 3 time-points for assessment of fecal calprotectin (FCAL). Use of HC included oral and vaginal intrauterine devices. Logistic regression analysis was used to assess the association between HC and IBD-related symptoms (IBDSI>14 for Crohn disease, >13 for ulcerative colitis), or inflammation (FCAL>250 ug/g) at any measurement point in the study. RESULTS: Of 71 women, 17 (24%) reported taking HC in the 1 year period. Adjusting for age, disease type, disease duration, and smoking status, the odds of having increased IBD-related symptoms (IBDSI) during the year were lower for women using HC compared with women not using HC [adjusted odds ratio 0.16, 95% CI, 0.02-0.90]. Conversely, women using HC were more likely to have inflammation during the year [adjusted odds ratio 5.7, 95% CI, 1.23-43.6]. CONCLUSIONS: HC use among women with IBD was associated with a lower likelihood of IBD-related symptoms but a higher likelihood of experiencing intestinal inflammation (FCAL>250 ug/g) over 1 year. Further work is needed to examine this dichotomous result, potentially examining aspects such as duration of HC use, and the types of HC.

Ultra-Processed Food, Disease Activity, and Inflammation in Ulcerative Colitis: The Manitoba Living With IBD Study.

INTRODUCTION: The purpose of this study was to investigate the relationship between ultra-processed food (UPF) consumption and (i) symptomatic disease and (ii) intestinal inflammation among adults with inflammatory bowel disease (IBD). METHODS: We identified participants (Crohn's disease [CD] and ulcerative colitis [UC]) from the Manitoba Living with IBD study. Active disease was defined using the IBD Symptom Inventory (score >14 for CD; >13 for UC); fecal calprotectin was measured for intestinal inflammation (>250 µg/g). Diet data were collected using the Harvard Food Frequency Questionnaire. UPF consumption was determined by the NOVA classification system. Percentage of energy consumption from UPFs was calculated and divided into 3 tertiles (T1 = low; T3 = high). Multiple linear regression analysis was used for active disease and inflammation predicted by UPF consumption. RESULTS: Among 135 participants (65% with CD), mean number of episodes of active disease (14.2 vs 6.21) and active inflammation (1.6 vs 0.6) was significantly higher among participants with UC in T3 compared with T1 of UPF consumption ( P < 0.05). When adjusting for age, sex, disease type, and duration, number of episodes of active disease was lower in T1 compared with T3 (ß = -7.11, P = 0.02); similarly, number of episodes of intestinal inflammation was lower in T1 (ß = -0.95, P = 0.03). No significant differences were observed among participants with CD. DISCUSSION: UPF consumption may be a predictor of active symptomatic disease and inflammation among participants with UC. Reducing UPF consumption is a dietary strategy that can be suggested for minimizing symptoms and inflammation among people living with IBD.

Real-World Risk of Recurrent Cardiovascular Events in Atherosclerotic Cardiovascular Disease Patients with LDL-C Above Guideline-Recommended Threshold: A Retrospective Observational Study.

INTRODUCTION: The 2021 Canadian Cardiovascular Society (CCS) guidelines recommend intensive low-density lipoprotein cholesterol (LDL-C) reduction for patients with atherosclerotic cardiovascular disease (ASCVD). For patients above LDL-C threshold on maximally tolerated statins, adding ezetimibe and/or a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) is recommended. This population-based, real-world study examined cardiovascular (CV) events in patients with ASCVD who are on statins and above current guideline threshold LDL-C levels. METHODS: Using administrative health data in Alberta, Canada, we identified patients with myocardial infarction (MI), ischemic stroke (IS), or peripheral artery disease with LDL-C > 1.8 mmol/L on statins between April 1, 2010 and March 31, 2016. Exploratory subgroups included very high-risk patients with ASCVD shown to derive the most benefit from PCSK9i intensification as identified by the CCS guidelines, including those with acute coronary syndrome (ACS) or recent MI. Frequencies and rates of individual and composite CV events (primary outcome: MI, IS, hospitalization for unstable angina, coronary revascularization, cardiovascular death; secondary outcome: MI, IS, CV death) were calculated over follow-up. RESULTS: The study included 32,984 patients with a mean (standard deviation) follow-up of 40.8 (21.0) months. Overall, 17.7% and 15.6% experienced a primary and secondary outcome, respectively, with rates of 5.58 and 4.83 per 100 patient-years, respectively. CV death and MI were the most common events. Subgroups with recurrent MI and comorbid diabetes exhibited higher CV event rates (23.6% and 22.2% had a primary outcome, respectively). Rates of CV events were notably high in patients with ACS or recent MI (49.4% and 54.0% had a primary outcome, respectively). CONCLUSION: This real-world study confirms that statin-treated high-risk patients with ASCVD and above-threshold LDL-C levels have substantial incidence of recurrent CV events. These findings reinforce the opportunity for lipid-lowering therapy intensification in high-risk patients to levels below guideline-recommended threshold in order to reduce CV risk.

Urgency for bowel movements is a highly discriminatory symptom of active disease in persons with IBD (the Manitoba Living with IBD study).

BACKGROUND: The Inflammatory Bowel Disease Symptom Inventory (IBDSI) is a validated patient self-reported measure used to assess IBD disease activity. There have yet to be more granular analyses on which symptoms are most associated with active disease. AIMS: To assess the prevalence of symptoms, and to examine which are most associated with disease activity as measured by a symptom index and objective measure of inflammation METHODS: The Manitoba Living with IBD Study is a prospective study of 156 participants with confirmed IBD who completed bi-weekly IBDSI. Relative risks (RR) and predictive values (NPV and PPV) were reported for each symptom to predict active disease defined as active IBDSI, self-reported flare and elevated faecal calprotectin (FCAL) (>250 µg/g). Analyses were undertaken following stratification based on sex, and disease type (Crohn's disease [CD] and ulcerative colitis [UC]). RESULTS: In total, 69.2% were female; 64.7% had CD. Fatigue was the most prevalent symptom in both inactive and active disease, across all three disease measures (IBDSI: 24.5% and 75.1%, self-reported flare: 42.2% and 72.2%, FCAL: 46.0% and 60.6%). The absence of fatigue had a high NPV for active IBDSI and self-reporting a flare in both CD and UC. Urgency had a consistently strong NPV and RR across all three disease measures in both IBD subtypes and sexes. The number of loose/liquid bowel movements predicted elevated FCAL in UC (RR males = 3.5, 95% CI 1.2-9.9, RR females = 1.8, 95% CI 1.2-2.7), as did blood in stool in UC females (RR = 1.8, 95% CI 1.2-2.7). In males with CD, excessive bowel gas (RR = 2.0, 95% CI 1.2-3.4) and urgency (RR = 3.9, 95% CI 1.6-9.3) best predicted an elevated FCAL. No symptom was strongly predictive of an elevated FCAL in CD females. CONCLUSIONS: Urgency was consistently associated with disease activity, irrespective of the disease measure. Fatigue was the most prevalent symptom irrespective of disease activity measure. Individual symptoms have different impacts on subjective (IBDSI) and objective (FCAL) measures in IBD.

Use of Benzodiazepines and Z-Drugs in Inflammatory Bowel Disease.

INTRODUCTION: We estimated the incidence and prevalence of benzodiazepine and Z-drug (separately and jointly as BZD) use in the inflammatory bowel disease (IBD) population compared with matched controls without IBD and examined the association of mood/anxiety disorders (M/ADs) with the use of BZD from 1997 to 2017. METHODS: Using administrative data from Manitoba, Canada, we identified 5,741 persons with incident IBD who were matched in a 1:5 ratio to controls on sex, birth year, and region. Validated case definitions were used to identify M/AD. Dispensations of BZD were identified. Multivariable generalized linear models were used to assess the association between IBD, M/AD, and BZD use. RESULTS: In 2016, the incident age/sex-standardized benzodiazepine use rates per 1,000 were 28.06 (95% confidence interval [CI] 26.41-29.81) in the IBD cohort and 16.83 (95% CI 16.28-17.39) in controls (adjusted rate ratio = 1.69 [95% CI 1.56-1.79]). Benzodiazepine incidence rates were higher for women with IBD than men, but the RR between cases and controls were similar for men and women. The incident age/sex-standardized Z-drug use rate per 1,000 was 21.07 (95% CI 19.69-22.41) in the IBD cohort. This was 1.87-fold higher than in controls (95% CI 1.73-2.01). In 2017, approximately 20% of persons with IBD used benzodiazepines and 20% used Z-drugs. There was a subadditive effect of both benzodiazepine and Z-drug uses between IBD and M/AD after adjusting for covariates. DISCUSSION: The use of BZD is more common in people with IBD than in population controls. Strategies to reduce the use of BZDs in persons with IBD and to offer alternative management strategies for M/ADs, sleep disorders, and other symptomatic concerns are needed.

Self-reported flares among people living with inflammatory bowel disease are associated with stress and worry but not associated with recent diet changes: The Manitoba Living with IBD Study.

BACKGROUND: In this matched case-control longitudinal study among people living with inflammatory bowel disease (IBD), we investigated beliefs about what triggers a flare. METHODS: Adults with confirmed IBD and active disease within 2 years were enrolled in the Manitoba Living with IBD Study and followed biweekly with online surveys for 1 year. The 7-point IBD Symptom Change Indicator was used for participant identification of a flare. Flare cases were matched to non-flare controls by sex and disease type. Members of each matched pair completed supplementary information on diet changes and psychological functioning in the previous 2 weeks and provided stool samples to assess fecal calprotectin (FCAL). RESULTS: Of 128 enrolled participants, 95 matched flare/non-flare pairs were created. Those reporting a flare were more likely to have elevated FCAL (51% vs 34% among non-flares, P = 0.043). Although 61% of study participants believed at baseline that a food may trigger flares, and 25% of those in a flare believed that a food may have triggered their current flare, there was no difference in consumption of assessed foods between flares and non-flares in the previous 2 weeks. Patients with flares were more likely to be having difficulties in emotional state than controls (40% vs 18%, P = 0.001) and more likely to be stressed or worried (64% vs 33%, P = 0.001). CONCLUSION: Although a majority of individuals with IBD believe that specific foods trigger their disease flares, this was not supported by the current findings. Recent psychological functioning was associated with self-reported IBD flare.

The association of efficacy, optimism, uncertainty and health anxiety with inflammatory bowel disease activity.

OBJECTIVE: Positive and negative psychological attributes have been shown to influence disease outcomes in many chronic health conditions. We aimed to evaluate the association between self-efficacy, optimism, health anxiety and intolerance of uncertainty and disease activity in inflammatory bowel disease (IBD). METHODS: Adults with confirmed and recently active IBD enrolled in a prospective cohort study. Demographics, disease information, validated measures of psychological functioning related to general self-efficacy, optimism, health anxiety and intolerance of uncertainty were collected at baseline, week 26 and week 52. Clinical disease activity was assessed using the Inflammatory Bowel Disease Symptom Inventory (IBDSI), self-reported flares, and intestinal inflammation using fecal calprotectin (FCAL), collected at baseline, weeks 26 and 52. Generalized estimating equations were used to test the association between psychological functioning and disease activity. RESULTS: Participants' (n = 154) mean age was 43.4 years (SD 12.5), 69.5% were women and 64.1% had Crohn's disease. Adjusting for demographic variables, higher self-efficacy was associated with lower likelihood of flare by self-report (odds ratio [OR] 0.80, 95% confidence interval [CI] 0.71, 0.91) and IBDSI (OR 0.89, 95% CI 0.80, 0.99), while higher health anxiety was associated with greater likelihood of flare by self-report (OR 1.07, 95% CI 1.01, 1.18) and higher symptomatic disease activity (IBDSI; OR 1.14, 95% CI 1.05, 1.24). The psychological attributes were not significantly associated with active disease as measured by inflammation (FCAL). CONCLUSION: General self-efficacy and health anxiety are relevant in understanding patient experience with disease activity, and may be appropriate targets for psychological intervention in the care of individuals with IBD.

The complex relationship between diet, symptoms, and intestinal inflammation in persons with inflammatory bowel disease: The Manitoba Living With IBD Study.

BACKGROUND: We aimed to examine whether an association exists between diet quality, based on the Prospective Urban Rural Epidemiology (PURE) Healthy Diet Score (HDS), and active inflammatory bowel disease (IBD). METHODS: Participants were drawn from the Manitoba Living With IBD Study cohort. The Harvard Food Frequency Questionnaire (FFQ) was used to calculate the HDS at two time points: baseline and 1-year follow-up. Using generalized estimating equations (GEE) logistic regression, we assessed the association between the HDS and (1) the IBD Symptom Inventory (IBDSI); (2) intestinal inflammation, measured by fecal calprotectin (FCAL); and (3) self-reported IBD flares. RESULTS: There were 294 completed FFQs among 153 people. Of these, 100% had completed data about an IBD flare, 98% had FCAL measurements, and 96% had completed IBDSI scores. On a HDS scoring method of 0-8, the odds of FCAL >250 mcg/g were lower for participants with a HDS of 4 vs 0-3 (adjusted odds ratio [OR], 0.38; 95% CI, 0.19-0.77). When applying a second HDS scoring method (8-40), the odds of having an IBD flare were 3.6 times greater with a HDS between 21 and 24 compared with an HDS ≤20 (adjusted OR, 3.63; 95% CI, 1.03-12.78). CONCLUSIONS: We found that active inflammation was less likely among those with a moderate HDS , whereas symptomatic IBD flares were more likely. People may choose to consume a moderate amount of healthy foods such as fruits and vegetables, even knowing that those foods may cause a symptomatic flare.

What Is a Flare? The Manitoba Living With IBD Study.

BACKGROUND: Flare is a poorly defined term used by patients and clinicians to indicate inflammatory bowel disease (IBD) status. This study aimed to evaluate the validity of a single-item 7-point flare indicator relative to other measures of disease flare. METHODS: The longitudinal Manitoba Living with IBD Study followed persons with IBD for 1 year; they completed biweekly online surveys and provided 3 stool samples. Disease flare on a single-item flare indicator with 7 possible responses developed for the study was defined by report of symptoms as "moderately" or "much" worse. The flare indicator was evaluated against 5 measures of disease activity: fecal calprotectin score (FCAL), a 2-point disease status indicator, a 4-point flare certainty indicator, the IBD Symptom Index short form (SIBDSI), and the short form IBD Questionnaire (SIBDQ). Participants in a flare, based on the 7-point measure, were matched to a nonflaring participant, and a stool sample was collected. RESULTS: Of the 155 IBD participants, almost half (n = 74) experienced a flare. Of those who flared, 97.0% endorsed active IBD on the 2-point indicator (controls 42.5%; P < .001); 91.9% endorsed active IBD on the 4-point certainty indicator (controls 32.9%; P < .001); 90.5% endorsed active disease on the SIBDSI (controls 34.2%; P < .001); and 48.5% had an elevated FCAL (controls 34.3%; P < .05). The mean SIBDQ was lower for the flare group compared with controls (43.9 [SD 11.1] vs 58.3 [SD 8.5]; P < .001), indicating worse disease. CONCLUSIONS: The 7-point flare indicator robustly identified symptomatic flares. This patient self-report indicator reflected meaningful changes in more complex clinical indices and had only weak concordance with the presence of inflammation.

Association Between Change in Inflammatory Aspects of Diet and Change in IBD-related Inflammation and Symptoms Over 1 Year: The Manitoba Living With IBD Study.

BACKGROUND: We aimed to investigate (1) the stability of inflammatory aspects of diet over 1 year among persons with inflammatory bowel disease (IBD) and (2) the impact of change in diet on changes in inflammation and IBD symptoms over 1 year. METHODS: Participants were recruited to the Manitoba Living with IBD Study and completed the Harvard Food Frequency Questionnaire (FFQ). The Dietary Inflammatory Index (DII) and the Empirical Dietary Inflammatory Index (EDII) were used to calculate the inflammatory potential of the diet. Inflammation was measured by fecal calprotectin (≥250 µg/g). Symptoms were measured by the IBD Symptom Inventory (IBDSI). All measures were obtained at baseline and 1 year. Dietary Inflammatory Index and Empirical Dietary Inflammatory Index scores >0 and <0 reflect pro- and anti-inflammatory diet, respectively. Variance components analyses were used to describe diet stability. Associations between changes in diet and changes in active inflammation and symptoms were assessed using ordinal logistic regression and multilevel linear regression modeling. RESULTS: One hundred thirty-five participants (66% CD) were included. Approximately one third of the variance in EDII (36%) and DII (33%) scores was explained by changes in diet over time. Each unit increase in the change in EDII (baseline to follow-up) was associated with a greater odds of FCAL, indicating active inflammation (>250 µg/g; odds ratio, 3.1; 95% confidence interval [CI], 1.02-9.93; P = 0.04) and with a rise in IBDSI of 6.7 (95% CI, 1.0-12.4; P = 0.022; theoretical IBDSI range, 0-81). There was no association between changes in DII and changes in FCAL or IBDSI. CONCLUSION: The EDII, but not the DII, may have utility to identify the inflammatory potential of diet. This inflammatory potential can contribute to inflammation and/or disease symptoms in persons with IBD.

Utility of the MARS-5 in Assessing Medication Adherence in IBD.

INTRODUCTION: We aimed to validate the Medication Adherence Report Scale-5 (MARS-5) as a tool for assessing medication adherence in inflammatory bowel disease (IBD) and to determine predictors of medication adherence. METHODS: One hundred twelve (N = 112) adults with confirmed IBD participating in the longitudinal Manitoba Living With IBD Study were eligible. Demographics, IBD type, surgeries, disease activity (using the Inflammatory Bowel Disease Symptom Inventory and fecal calprotectin levels), perceived stress, and medication use were collected biweekly through online surveys. The MARS-5 scores were obtained at baseline and at 1 year. Correlation between medication monitoring data and MARS-5 scores was performed and the optimal MARS-5 cutoff point for adherence assessment determined. Predictors of medication adherence were assessed at both ≥90% and ≥80%. RESULTS: Participants were predominantly female (71.4%), mean age was 42.9 (SD = 12.8), and the majority (67.9%) had Crohn disease (CD). Almost half (46.4%) were taking more than 1 IBD medication, with thiopurines (41.9%) and biologics (36.6%) the most common. Only 17.9% (n = 20) were nonadherent at a <90% level; of those, 90% (n = 18) were using oral medications. The MARS-5 was significantly associated with adherence based on medication monitoring data at baseline (r = 0.48) and week 52 (r = 0.57). Sensitivity and specificity for adherence ≥80% and ≥90% were maximized at MARS-5 scores of >22 and >23, respectively. Having CD (OR = 4.62; 95% confidence interval, 1.36-15.7) was the only significant predictor of adherence. CONCLUSION: MARS-5 is a useful measure to evaluate adherence in an IBD population. In this highly adherent sample, disease type (CD) was the only predictor of medication adherence.

Ipilimumab-Induced Enterocolitis: A Systematic Review and Meta-Analysis.

INTRODUCTION: Checkpoint inhibitor drugs including ipilimumab have been reported to induce intestinal injury. OBJECTIVE: We aimed to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration, and the likelihood that an enteritis vs colitis or enterocolitis is seen. PATIENTS AND METHODS: We searched MEDLINE, EMBASE, CENTRAL, the World Health Organization International Clinical Trials Registry, and conference proceedings. We included: (1) randomized controlled trials comparing ipilimumab administration with placebo/standard care/other active chemotherapy regimens and (2) prospective observational studies. Separate meta-analyses were performed for randomized controlled trials and observational studies. RESULTS: Of 4760 records, we included ten unique randomized controlled trials (n = 5814 subjects) and 34 unique prospective observational studies (n = 3699 subjects). In randomized controlled trials, the pooled relative risk of ≥ grade 3 enterocolitis or ≥ grade 3 diarrhea associated with ipilimumab was 13.31 (95% confidence interval 6.01-29.48, I2 = 0%, ten trials) and 6.72 (95% confidence interval 3.30-13.65, I2 = 63%, ten trials), respectively. In observational studies, the 3-monthly risk of developing grade 3 or higher enteritis, colitis, or enterocolitis was 4% (95% confidence interval 3-7, I2 = 77.40%, 25 studies). Randomized controlled trials and observational studies did not distinguish between acute and chronic enterocolitis. Of the included observational studies, the pooled risk of incurring small bowel involvement associated with ipilimumab was 1% (95% CI 0-4, I2 = 0%, four studies) per every 3-month time period. CONCLUSIONS: Insufficient data exist to quantify or distinguish the risk of acute vs chronic enterocolitis following ipilmumab use. Because of the serious impact of chronic enterocolitis on quality of life and further cancer treatment, future trials evaluating the safety of immunotherapy should report gastrointestinal events in greater detail.

Brain Resting-State Network Alterations Associated With Crohn's Disease.

Inflammatory bowel disease (IBD) is a chronic disease that is associated with aspects of brain anatomy and activity. In this preliminary MRI study, we investigated differences in brain structure and in functional connectivity (FC) of brain regions in 35 participants with Crohn's disease (CD) and 21 healthy controls (HC). Voxel-based morphometry (VBM) analysis was performed to contrast CD and HC structural images. Region of interest (ROI) analyses were run to assess FC for resting-state network nodes. Independent component analysis (ICA) identified whole brain differences in FC associated with resting-state networks. Though no structural differences were found, ROI analyses showed increased FC between the frontoparietal (FP) network and salience network (SN), and decreased FC between nodes of the default mode network (DMN). ICA results revealed changes involving cerebellar (CER), visual (VIS), and SN components. Differences in FC associated with sex were observed for both ROI analysis and ICA. Taken together, these changes are consistent with an influence of CD on the brain and serve to direct future research hypotheses.

The Relationship Between Adverse Childhood Experiences and Health Care Use in the Manitoba IBD Cohort Study.

BACKGROUND: We aimed to determine the prevalence of adverse childhood experiences (ACEs) in persons with inflammatory bowel disease (IBD) and whether having ACEs was associated with health care utilization post-IBD diagnosis. METHOD: Three hundred forty-five participants from the population-based Manitoba IBD Cohort Study self-reported ACEs (ie, physical abuse, sexual abuse, death of a very close friend or family member, severe illness or injury, upheaval between parents, and any other experience thought to significantly impacts one's life or personality) at a median of 5.3 years following IBD diagnosis. Cohort study data were linked to administrative health databases that captured use of hospitals, physician visits, and prescription drugs; use was classified as IBD-related and non-IBD-related. Mean annual estimates of health care use were produced for the 60-month period following the ACE report. Generalized linear models (GLMs) with generalized estimating equations (GEEs) with and without covariate adjustment were fit to the data. RESULTS: The prevalence of at least 1 ACE was 74.2%. There was no statistically significant association between having experienced an ACE and health care use. However, unadjusted mean annual non-IBD-related general practitioner visits were significantly higher for participants exposed to physical and sexual abuse than those not exposed. Selected adjusted rates of IBD-related health care use were lower for participants who reported exposure to an upheaval between parents and high perceived trauma from ACEs. CONCLUSION: The estimated prevalence of at least 1 self-reported ACE in persons with diagnosed IBD was high. Health care use among those who experienced ACEs may reflect the impacts of ACE on health care anxiety.

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

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.