Associate Professor of Medicine
University of California, San Francisco

An expert in inflammatory bowel disease, particularly as it related to pregnancy and fertility, new drug trials and pouchitis, Dr. Uma Mahadevan serves as director of clinical research at the UCSF Center for Colitis and Crohn's disease. In addition to caring for patients with inflammatory bowel disease (IBD), she is interested in developing novel therapies for the condition, as well as investigating pregnancy and fertility outcomes in IBD.

Mahadevan received her medical degree from State University of New York and completed her residency in internal medicine at Mount Sinai Medical Center in New York. She then went on to complete her fellowship in gastroenterology at UCSF and inflammatory bowel disease at Mayo Clinic, Rochester, Minn. Her research on inflammatory bowel disease has been widely published in medical journals and books. Currently, Mahadevan holds the position of assistant clinical professor of medicine at UCSF.

University of California, San Francisco

The UCSF Inflammatory Bowel Disease Center provides comprehensive care for patients with Crohn's disease, ulcerative colitis, microscopic or collagenous colitis and related illnesses. Our center is dedicated to patient care, doctor and patient education as well as clinical and basic science research to find a cure for the disease. Recent advancements in our understanding of the pathophysiology of inflammatory bowel disease (IBD) are rapidly increasing the therapeutic options for IBD, and we are at the forefront of studying the various new drugs to treat the disease.

The center's team of experts includes adult and pediatric gastroenterologists, surgeons, radiologists, pathologists, immunologists, nutritionists, psychologists, ostomy nurses and social workers. This team meets regularly to discuss cases and devise optimal treatment plans. Therapy is always directed at improving the quality of life of our patients with these diseases, and therefore their input regarding treatment decisions is of critical importance.


Gastroenterology at Mount Zion specializes in the prevention, diagnosis and treatment of diseases of the liver and digestive tract, including the esophagus, stomach, duodenum, gallbladder, biliary tract, pancreas, small intestine and colon.

Our specialists are involved in research to better understand digestive disorders and to develop new therapies. Many of our patients participate in clinical trials to test new treatments for disorders including ulcerative colitis and Crohn's disease.

 The Association between Fatigue and Carnitine Status in Crohn’s Disease

Background: Fatigue is an increasingly recognized cause of morbidity amongst Crohn’s disease (CD) patients, even in patients with disease in remission. Though fatigue is likely multifactorial in CD, the impact of micronutrient deficiencies has not been extensively explored. Carnitine is a naturally-occurring amino acid derivative that plays a pivotal role in fatty acid oxidation and energy metabolism. Carnitine deficiency has been associated with fatigue in many diseases, including renal failure, congestive heart failure, and celiac disease. To date, there have been no studies evaluating carnitine status in CD patients.

Methods: This is a prospective cross-sectional study of CD patients at a single referral center for inflammatory bowel disease. All patients had histological evidence of CD and disease activity was assessed by Harvey-Bradshaw Index (HBI). Exclusion criteria included glucocorticoid treatment or surgery within 6 months of recruitment, and significant renal or liver disease. Fatigue was measured in all subjects with the Multidimensional Fatigue Inventory (MFI). In addition, patients were also screened for depression, sleep disturbances, and anemia with questionnaires/laboratory tests within 30 days of fatigue assessment.

 Clinical Utility of anti-JC Virus Antibody Testing in Crohn's Disease

Rate of Seropositivity and Impact on Therapy with Natalizumab BACKGROUND: Natalizumab (NAT), an alpha-4 integrin inhibitor, is effective for the treatment of multiple sclerosis (MS) and Crohn's disease (CD). However, its use is limited by a 1.3 in 1000 risk of progressive multifocal leukoencephalopathy (PML), caused by JC virus reactivation. An ELISA-based assay for anti-JC virus antibody (anti-JCV Ab) has recently become commercially available, and preliminary studies in MS suggest this test may be useful in risk-stratifying patients for NAT therapy. However, the utility of anti-JCV Ab testing in the management of CD has not yet been evaluated.

METHODS: We performed a retrospective cross-sectional study to determine the rate of anti-JCV seropositivity in CD. A total of 30 patients (12 being considered for NAT therapy because of failure/loss of response to second anti-TNF therapy, 18 already on NAT) were included. We then determined the rate of therapy discontinuation within 60 days of anti-JCV testing among the 18 patients on NAT, based on results of anti-JCV Ab testing and duration of treatment (<11 months vs =11 months).

 Environmental Changes and the onset of Inflammatory Bowel Disease (IBD) in the Migrant South Asian Population

Background: The increase in the incidence of IBD in South Asian patients over the past 2 decades has been attributed to both genetic and environmental factors. A comprehensive evaluation of hygiene and dietary changes among the Indian diaspora to the US has never been conducted.

Methods: In this pilot study, we administered a questionnaire to first generation Indian immigrants with IBD in Northern California. The questions were extensive and involved changes in diet, stress, hygiene and lifestyle after immigration from India to the USA.

 PIANO: A 1000 Patient Prospective Registry of Pregnancy Outcomes in Women with IBD Exposed to Immunomodulators and Biologic Therapy

Introduction: Women with IBD and their physicians have concerns regarding the safety of biologic and immunosuppressant medication use during pregnancy. Data regarding the safety of these medications are sparse due to limited sample size at any one center and lack of uniform data collection methods. We created a prospective cohort of pregnant women at 30 US IBD centers to determine whether the complication rates are higher among women with IBD and their offspring who are exposed to azathioprine (AZA), 6-MP, or anti-TNF agents during pregnancy compared to women with IBD who do not take these medications.

Methods: Pregnant women with IBD were prospectively enrolled and contacted every trimester, at the birth of their baby, and at 4, 9, and 12 months of age. Newborn complications for the first year of life and the mothers’ medications, disease activity and complications of pregnancy were recorded. Patients were divided into four groups according to exposure between conception and delivery: Unexposed (no thiopurines or anti-TNF agents); Group A (6MP/AZA); Group B (infliximab, adalimumab, certolizumab) and Group AB (both thiopurines and anti-TNF).

 Early Serum Infliximab Levels in Severe Ulcerative Colitis. (EaSiFx)

The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely correlated with serum infliximab levels.

In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab, we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively associated with clinical response and avoidance of colectomy.

Estimated Enrollment: 10
Study Start Date: November 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

 Study to Determine Risk Factors for Post-operative Infection in Inflammatory Bowel Disease (PUCCINI)

Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery.

By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases.

If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.

Estimated Enrollment: 1000
Study Start Date: February 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

 A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

Principal Investigator: Uma Mahadevan-Velayos

Purpose: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to one year from birth. We are looking for 660 pregnant women to enroll in the duration of 3 years.

Estimated Enrollment: 1000
Study Start Date: August 2007
Estimated Study Completion Date: December 2012

Eligibility
Ages Eligible for Study: 18 Years to 45 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No

Sampling Method: Non-Probability Sample

Study Population
Female patients with confirmed IBD diagnoses who are pregnant

Criteria
Inclusion Criteria:
•Female patients with confirmed IBD diagnoses who are pregnant

Exclusion Criteria:
•Pregnant female patients younger than 18 years of age
•Confirmed multiple gestation