PRECONCEPTION AND PREGNANCY IN IBD CLINICAL RESEARCH PROGRAMS
Lead investigator: Dr. Vivian Huang (University of Alberta and University of Toronto)
Co-investigators and Collaborators (University of Alberta): Dr. Levinus Dieleman, Dr. Karen Madsen, Dr. Richard Fedorak, Dr. Eytan Wine, Dr. Shokrollah Elahi, Dr. Daniel Sadowski (RAH), Dr. Karen Kroeker (UAH), Dr. Brendan Halloran (UAH), Dr. Sander van Zanten (UAH), Dr. Robert Bailey (RAH), U of A Division of Gastroenterology, Dr. Mike Kolber (UAH family medicine), Dr. Rshmi Khurana (RAH obstetrical medicine) , Dr. Radha Chari (RAH maternal fetal medicine obstetrics), Lois Hole Clinical Research Unit (RAH), WCHRI, CEGIIR
Co-investigators and Collaborators (Mount Sinai Hospital, University of Toronto): Dr. Geoffrey Nguyen, Dr. Hillary Steinhart, Dr. Mark Silverberg, Dr. Ken Croitoru, Dr. Adam Weizman, Dr. Cynthia Maxwell.
Contact (University of Alberta): email@example.com
Contact (Mount Sinai Hospital, University of Toronto): Vivian.Huang@sinaihealthsystem.ca
About us: The clinical research programs aim to improve clinical management of IBD to improve outcomes for mothers with IBD and their infants, and to study the complex interaction between maternal IBD, pregnancy, and the neonate.
The programs include
1) a consultation clinic for women with IBD who are preconception, pregnant, and post partum
2) “bench to bedside” research studies to understand the interaction between maternal IBD and pregnancy, and impact on the infant
3) “bench to bedside” research studies to find biomarkers to assistant in the management of IBD during pregnancy,
4) educational research studies to improve knowledge regarding pregnancy and IBD.
INTERESTED or HAVE QUESTIONS? Wish to participate or volunteer?
If you are interested in participating in any of the studies, please email us at firstname.lastname@example.org (Edmonton) or Vivian.Huang@sinaihealthsystem.ca (Toronto).
CLINICAL OUTCOMES STUDIES
a) Counseling to Optimize Medication Adherence in Expectant Mothers with Inflammatory Bowel Disease (COACH-IBD) Study: In this randomized controlled trial of patient-centered counseling incorporating motivational interviewing and telemedicine-based follow-up by an IBD nurse, we hope to show that this additional counseling can improve medication adherence and pregnancy outcomes. We also hope to validate the use of self-reported medication adherence during pregnancy in the IBD population. This study is being conducted out of Mount Sinai Hospital, Toronto and University of Calgary, Calgary.
b) Improving maternal and neonatal outcomes in IBD with a dedicated clinic: We hope to show that a dedicated clinical follow up and counselling can improve outcomes for mothers with IBD and their infants.
c) Quality of Life in pregnancy in women with IBD: We are studying how pregnancy may affect the quality of life for pregnant women with IBD.
d) Medication adherence during pregnancy in women with IBD: We hope to show that a dedicated clinic with routine clinical follow up and counselling can improve medication adherence,.
e) Biomarkers for predicting IBD disease activity in pregnancy and IBD: We are studying the fecal calprotectin (FCP) stool test, which should ONLY be elevated from inflammation in the intestines, to see if it can help guide the management of IBD during pregnancy.
TRANSLATIONAL RESEARCH STUDIES
Baby G.E.M. (genetics, environment, microbiome) study aims to establish a cohort of infants born to mothers with IBD, and collect data and samples from birth, so that we may be able to better understand early risk factors for IBD.
The MOM MII (Maternal Offspring Microbiome, Metabolomic, and Immunologic profiling in IBD) study was initiated in 2015 with the aims to investigate the impact of pregnancy on maternal IBD, and the impact of maternal IBD and therapies on neonatal outcomes and the infant’s future health during childhood.
MOM MII studies include the following
a) Maternal immunosuppressive IBD medications may result in neonatal immune dysregulation. (Co-investigator Dr. S. Elahi, funding from WCHRI Innovation grant): We are investigating the immune profile of pregnant women with IBD and the immune profile of the neonate at birth. This will give clinicians and scientists a better understanding of the impact of maternal IBD disease, disease activity, and IBD therapies, on the fetus and neonate.
b) Cytokine profiling in women with IBD during pregnancy: We are studying the changes in pro-inflammatory and anti-inflammatory cytokines during pregnancy and post partum in women with IBD and healthy volunteers. A better understanding of the complex interactions between pregnancy and IBD will help guide management of IBD in pregnancy.
c) Influence of Maternal IBD on Neonatal Gut Microbiome: Determining if Our Mothers are Responsible for our Dysbiotic Microbiome and Subsequent IBD (co-investigator Dr. K Madsen, funding from FLIBD grant): Breast milk contains many healthy components such as nutrients, antibodies, fats, oligosaccharides, and bacteria, which help the infant establish their microbiome. We are studying how IBD and IBD therapies may affect breast milk composition, and whether this then affects the infants.
d) Urine and serum metabolomics to predict IBD disease activity in pregnancy. (co-investigators Dr. Madsen, Dr. Fedorak, Dr. Dieleman, funding from Clinical Research and Progress (CRAP) grant, CEGIIR): Through urine and serum metabolomic profiling of both pregnant IBD women and pregnant control (non IBD) women, we hope to analyze any differences between metabolites produced during preconception through T3 that could be used as indicators of flaring, remission, or adverse fetal outcomes.
KNOWLEDGE TRANSLATION PROGRAM
a) Improving Knowledge of Reproductive Issues in Inflammatory Bowel Disease web portal (funding from AIHS Knowledge to Action grant): Many IBD patients have concerns regarding pregnancy due to negative views and unfounded concerns about their disease or medications. We developed and assessed a web portal with the aim of improving IBD patient’s knowledge and concerns regarding pregnancy. The study is now closed to recruitment; our website does improve knowledge, increasing patient’s CCPKnow scores, and reduces concerns about pregnancy and IBD.
b) A decision-making tool to help women with IBD and their health care team make informed decisions regarding the management of IBD during pregnancy and peripartum. (funding from WCHRI CRISP grant): Together with patient representatives, multidisciplinary care providers, and knowledge translation experts, we will develop decision aides for patients with IBD to help them make decisions about their IBD management in their journey from preconception, pregnancy, peripartum, and post partum.