Current Clinical Trials 

Clinical trials of new and emerging therapies potentially offer the patient a more effective treatment. Much is happening in basic, translational and clinical research for IBD. Our clinicians interact closely with immunologists, microbiologists, geneticists, pathologists and other scientists at the University of Chicago who are working in the field of digestive diseases. Current studies are looking at the many genes associated with IBD and the role of intestinal microflora in contributing to the disorder. Whatever the area of research, we all have the same goals: to develop better and more specific treatments for IBD and ultimately to prevent and cure the disease


 

Ethnic variation of thiopurine methyltransferase enzyme activity and risk of adverse events in patients with inflammatory bowel disease

Azathioprine (AZA) and 6-mercaptopurine (6-MP) are thiopurine drugs widely used in the management of inflammatory bowel disease (IBD). Thiopurine methyltransferase (TPMT) enzyme is involved in the metabolism and side effect of thiopurine drugs.

The aim of this study is to compare TPMT activities and major AZA/6-MP associated side effects in 3 ethnic groups.


Sofia MA - DDW 2018 (1).PNG

Poor sleep quality is a risk factor for hospitalization and surgery in Crohn’s disease

Sleep disturbances are common and a source of reduced quality of life in people with Crohn’s disease (CD). While active IBD promotes poor sleep, evidence suggests that poor sleep quality is associated with objective disease activity and risk for clinical relapse. Sleep physiology is closely associated with immune regulation, and sleep disturbances have a bidirectional relationship with inflammatory dysregulation. 

We aim to assess whether poor sleep quality is a risk factor for hospitalization or surgery in CD.


Sleep fragmentation measured by a wearable device is an indicator of clinical disease activity in inflammatory bowel disease

Sleep dysfunction in inflammatory bowel disease (IBD) is associated with histologic inflammatory activity and risk for clinical disease relapse. Passive measurement of sleep by a wearable device can identify patterns of sleep dysfunction.

Our aim is to assess whether remotely measured sleep quality by a wearable device is associated with clinical disease activity.

Sofia MA - DDW 2018 (0).PNG

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A Comparison of the Risk of Postoperative Recurrence between African-American and Caucasian Crohn’s Disease Patients

Literature on racial differences in postoperative recurrence in CD is extremely limited. Studies have suggested that African-American (AA) patients with Crohn’s Disease have a more severe course than Caucasians (CAU). To date, there are no studies that assess racial differences in recurrence in CD.


Fecal calprotectin is a very reliable tool to predict and monitor the risk of relapse after therapeutic de-escalation in patients with inflammatory bowel diseases

Selecting patients who may benefit from therapeutic de-escalation (TDE) and monitoring them is a concern and a clinical challenge in inflammatory bowel diseases (IBD). The role of fecal calprotectin (Fcal) remains poorly investigated in these situations. 

Our aim is to assess Fcal levels before TDE as a predictor of clinical relapse and to evaluate serial measurements of Fcal to predict clinical relapse after TDE.

Buisson A - DDW 2018 (3).PNG

Buisson A - DDW 2018 (2).PNG

Fecal calprotectin is highly effective in detecting endoscopic ulcerations in Crohn’s disease regardless of disease location

The reliability of fecal calprotectin (Fcal) remains debatable in detecting endoscopic ulcerations in patients with isolated ileal Crohn’s disease (CD).

We aim to compare the reliability of Fcal in patients with isolated ileal CD to those observed in patients with colonic or ileocolonic location.


Histological activity in Crohn’s disease: relationship with clinical indices, endoscopic activity and fecal calprotectin

The impact of histological remission is currently being investigated in patients with Crohn’s disease (CD).

In this study, we aim to assess the relationship between histological activity and 1) clinical activity, 2) endoscopic activity or 3) fecal calprotectin (Fcal), which are still unknown in CD.


Buisson A - DDW 2018.PNG

Combination therapy with anti-TNF and immunosuppressive therapies is the most effective medication to prevent and treat endoscopic postoperative recurrence in patients with Crohn’s disease

Postoperative recurrence (POR) is a major concern in patients with Crohn’s disease (CD).  Anti-TNF agents are considered the most effective medications to prevent and to treat endoscopic postoperative recurrence in CD.

We assessed the factors associated with the efficacy of anti-TNF agents to prevent endoscopic or clinical POR especially prior anti-TNF exposure, prior primary non-response to anti-TNF before surgery and concomitant use of immunosuppressive therapy.


Tofacitinib for the Induction and Maintenance of Medically-resistant Ulcerative Colitis

Tofacitinib is an oral, non-selective inhibitor of the Janus kinase (JAK) family, mainly JAK 1 and 3. Its effectiveness for induction and maintenance of remission in ulcerative colitis (UC) has been demonstrated in recent phase 3 trials.

Here we describe our off-label experience with the use of tofacitinib for induction and maintenance of  refractory moderate to severe UC.

Weisshof R - DDW 2018.PNG

Lei DK - DDW 2018.PNG

Longer Duration of Vancomycin Prevents Recurrence of Clostridium difficile in Patients with Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) patients acquire Clostridium difficile infections (CDI) at higher rates than the general population and have worse outcomes when infected.  

We evaluated the association between duration of oral vancomycin therapy and the rates of CDI recurrence and reinfection in IBD patients.


rates of Ustekinumab deep remission: a real-world tertiary care center experience

Ustekinumab (UST), a monoclonal antibody against the p40 subunit of IL-12 and IL-23, is FDA approved for the treatment of plaque psoriasis and moderate to severe Crohn’s disease (CD).  

In this real-world experience with UST at a single center pre- and post-approval for CD, we demonstrate that UST successfully induces deep remission in patients with active disease. However, a large percentage of patients who achieve clinical remission continue to have elevated objective inflammatory markers. 

Cleveland NK - DDW 2018.PNG

Histological activity in Crohn’s disease: relationship with clinical indices, endoscopic activity and faecal calprotectin

The impact of histological remission is currently being investigated in patients with Crohn’s disease (CD). 

In this study, we aim to assess the relationship between histological activity and 1) clinical activity, 2) endoscopic activity or 3) faecalcalprotectin (Fcal), which are still unknown in CD.


Fecal calprotectin is highly effective in detecting endoscopic ulcerations in Crohn’s disease regardless of disease location

The reliability of fecal calprotectin (Fcal) remains debatable in detecting endoscopiculcerations in patients with isolated ileal Crohn’s disease (CD).

We aim to compare the reliability of Fcalin patients with isolated ileal CD to those observed in patients with colonic or ileocoloniclocation.


Faecal calprotectin is a very reliable tool to predict and monitor the risk of relapse after therapeutic de-escalation in patients with inflammatory bowel diseases

Selecting patients who may benefit from therapeutic de-escalation (TDE) and monitoring them is a concern and a clinical challenge in inflammatory bowel diseases (IBD). The role of faecalcalprotectin (Fcal) remains poorly investigated in these situations. 

Our aim is to assess Fcal levels before TDE as a predictor of clinical relapse and to evaluate serial measurements of Fcal to predict clinical relapse after TDE.


Natural history of Crohn’s disease postoperative recurrence in a referral center in the era of biologics and therapeutic intensification based on early endoscopic findings

The performance of available risk factors in predicting endoscopic postoperative recurrence (POR) remain poor in Crohn’s disease (CD).

Incontrast, the Rutgeerts’ index assessed within the first year after the surgery is highly predictive of clinical POR.

 Therapeutic intensification in cases of early endoscopic POR is now recommended.

However, these factors have been identified in different studies, which were mostly conducted before the wide use of biologics to prevent endoscopic POR.

We aimed to assess the prevalence and the risk factors of endoscopic and clinical POR in the era of biologics and therapeutic intensification based on early endoscopic findings in CD.


HISTOLOGICAL HEALING IS ASSOCIATED WITH DECREASED CLINICAL RELAPSE IN PATIENTS WITH ILEAL CROHN’S DISEASE

Mucosal healing has emerged as a goal of maintenance therapy in patients with Crohn’s disease and is associated with improved clinical outcomes. 

The role of histological healing is less well defined. 

This study examines if histological healing is associated with improved clinical outcomes in patients with Crohn’s disease confined to the terminal ileum.


Longer Duration of Vancomycin Prevents Recurrence of Clostridium difficile in Patients with IBD

Inflammatory Bowel Disease (IBD) patients acquire Clostridium difficile infections (CDI) at higher rates than the general population and have worse outcomes when infected.

IBD patients are 33% more likely to have a recurrence of CDIs than the general population.

There are no guidelines for treating CDIs in IBD patients, but guidelines suggest 10-14 days of oral vancomycin for severe CDI in the general population.

We evaluated the association between duration of oral vancomycin therapy and the rates of CDI recurrence and reinfection in IBD patients.


Faecal calprotectin in assessing endoscopic and histologic remission in patients with ulcerative colitis

Persistent active endoscopic and histological inflammation are associated with poorer outcomes in ulcerative colitis (UC). Feacal calprotectin is a surrogate marker of endoscopic and histological remission. 

We studied the correlation between feacal calprotectin and endoscopic or histological disease activity in order to define the optimal cut-off value to detect endoscopic and histological remission.


Sleep fragmentation measured by wearable device is an indicator of clinical disease activity in inflammatory bowel disease

Wearable activity monitors allow individuals to track physical characteristics, including sleep patterns. Sleep dysfunction in inflammatory bowel disease (IBD) is associated with histologic inflammatory activity and risk for clinical disease relapse. Passive measurement of sleep by a wearable device can identify patterns of sleep dysfunction.

Here we aim to to assess whether remotely measured sleep quality by a wearable device is associated with clinical disease activity.


Poor sleep quality is a risk factor for hospitalization and surgery in Crohn’s disease

Sleep disturbances are common and a source of reduced quality of life in people with Crohn’s disease (CD). While active IBD promotes poor sleep, evidence suggests that poor sleep quality is associated with objective disease activity and risk for clinical relapse. Sleep physiology is closely associated with immune regulation, and sleep disturbances have a bidirectional relationship with inflammatory dysregulation.

Here we aim to assess whether poor sleep quality is a risk factor for hospitalization or surgery in CD.


Tofacitinibfor the induction and maintenance of medically-resistant ulcerative colitis

Many inflammatory bowel disease (IBD) patients are unresponsive to medical therapy or lose response with time.

Tofacitinibis an oral, non-selective inhibitor of the Janus kinase (JAK) family, focused mainly in vivo at JAK 1 and 31. Its effectiveness for induction and maintenance of remission of ulcerative colitis (UC) has been demonstrated in recent phase 3 trials2.

 Here we describe our off-label experience with the use of tofacitinibfor induction and maintenance of  refractory moderate to severe IBD patients.


IBD Patient Compliance with Mobile Technologies Used for Monitoring Sleep Quality, Pain and Quality of Life

Improving health-related quality of life (HRQoL) is a primary treatment goal for patients with inflammatory bowel disease (IBD). Sleep quality and pain can be used to assess components of HRQoL. We aimed to determine the feasibility and reliability of simplified daily HRQoL and sleep quality data collection in patients with IBD using mobile technology.


Simplified Daily Assessments of Sleep Quality, Pain and Quality of Life in IBD Patients Correlate with Validated Measures

Improving health-related quality of life (HRQoL) is a primary treatment goal for patients with inflammatory bowel disease (IBD). Sleep quality and pain can be used to assess components of HRQoL. We aimed to determine the feasibility and reliability of simplified daily HRQoL and sleep quality data collection in patients with IBD using mobile technology.


Do Nurses and Physicians Know How Much Pain and Anxiety Their IBD Inpatients Have?

Pain and anxiety are common symptomsin patients with inflammatory bowel disease (IBD), which negatively affect their quality of life. Addressing and alleviating IBD patients’ pain and psychological distress are important goals of management, but it is not known whether patients’ subjective reporting of these factors align with physicians’ (MDs) and nurses’ (RN/APNs) assessments. We evaluated the correlations of IBD patients’ pain and anxiety among patients, RN/APNs and MDs.


Ustekinumab Provides Steroid-Sparing and Perianal Improvement in IBD Patients: Single Center Experience

Ustekinumab (UST), a monoclonal antibody against the p40 subunit of IL-12/IL-23. It is FDA approved for the treatment of plaque psoriasis and moderate to severe Crohn’s disease (CD). We report our experience with this therapy in our inflammatory bowel disease (IBD) population before and after FDA approval.


Management of Patients with Inflammatory Bowel Disease, Pneumocystis jiroveciiand Human Immunodeficiency Virus Infection

There are limited data on Crohn’s disease (CD) natural history in the presence of HIV and the safety of available treatments. We report a patient with CD who presented with pneumocystis jiroveciipneumonia (PJP) secondary to acquired immunodeficiency syndrome and discuss the treatment options.


Squamous Cell Carcinoma of the Tongue in a Crohn’s Disease Patient

Tongue lesions are an uncommon extra-intestinal manifestation of inflammatory bowel disease (IBD) and require a careful evaluation in order to make an accurate diagnosis and institute early treatment. Clinicians managing IBD should be aware of the differential diagnosis of tongue lesions and in at-risk patients, perform careful examinations and refer for early tissue diagnosis.


An Interactive Smoking Cessation Program Provides No Difference in Motivational Benefit Over Passive Materials in Crohn’s Disease

Smoking cessation is an important quality measure for Crohn’s disease treatment, but effective methods of smoking cessation for this population have not yet been clearly defined. Here we examined behavioral support, assessing the effect of interactive media on patients’ motivation to quit smoking and compliance to a smoking cessation program.


Use of Tofacitinibfor the Treatment of Arthritis Associated with Vedolizumab in Ulcerative Colitis

Tofacitinibis a Janus kinase 1-3 inhibitor currently approved for treatment of rheumatoid arthritis, but has demonstrated efficacy for moderate to severe ulcerative colitis (UC) in phase 3 trials. We present a case of a patient with both UC and inflammatory arthritis.


Real World Experience of UstekinumabTherapy in Patients at a U.S. Tertiary Inflammatory Bowel Disease Center

In this real-world experience with UST at a single center pre- and post-approval for CD, we demonstrate a high rate of response and remission in a sick CD population that had failed anti-TNF therapy, including many with perianal disease.


Poor Sleep Quality in Crohn's Disease is Associated with Antibiotic use and GERD Symptom Severity

Poor sleep quality is an important determinant for QoL in IBD. Sleep disturbances have been independently observed in patients with Crohn's disease (CD) and in patients with gastroesophageal reflux disease (GERD). However the impact of GERD on sleep quality in CD is unknown. We investigated the association between CD activity and GERD symptoms with sleep quality in patients with CD.


Patients with UC and Concomitant PSC Have more subclinical endoscopic and histologic disease activity in the right colon compared to UC patients without psc

Primary sclerosing cholangitis (PSC) is a potent independent risk factor for colorectal cancer (CRC) in ulcerative colitis (UC) patients, particularly right-sided colon cancer. However, the etiopathogenesis is not known. Given that chronic inflammation is a risk factor for CRC in UC, we hypothesized that patients with UC and concomitant PSC (UC-PSC) may have more active subclinical disease than patients with UC alone.


Demographic and Healthcare factors associated with patient utilization of technology to manage their IBD

While it is known that inflammatory bowel disease (IBD) patients are increasingly utilizing technology to acquire information for a host of medical conditions, little is known in general about this usage among IBD patients, or how this usage is related to patient characteristics and healthcare.

In this large U.S.-wide on-line assessment of health care access in IBD, a majority of patients reported using computers to learn about IBD, as well as to facilitate aspects of disease management. Demographic factors associated with use of online chat and support groups included respondents who had lower income, lower educational attainment and who were younger. These findings can inform future interventions to improve communication and access to care.