GEM Project
Research type
Research Study
Full title
The Genetic Environmental Microbial (GEM) Project. A Multidisciplinary Human Study on the Genetic, Environmental and Microbial Interactions that Cause Inflammatory Bowel Disease
IRAS ID
153343
Contact name
Charlie Lees
Contact email
Sponsor organisation
University of Edinburgh
Research summary
The Genetic Environmental Microbial (GEM) Project is a prospective cohort study assessing healthy siblings or offspring (aged 6-35 years of age) of patients diagnosed with Crohn’s disease, a long-term condition that causes inflammation of the lining of the digestive system. GEM aims to understand and identify the interactions between human genetics, environmental changes, and microbial changes that contribute to the development of Crohn’s disease. The goal is to find the causes or triggers of Crohn’s disease, by determining why some first degree relatives develop disease, while others do not. GEM is organised by Mount Sinai Hospital in Canada and has successfully recruited over 1500 adult and 1300 paediatric subjects from sites across North America and Israel. GEM has been extended to the EEA to meet the overall target of 5000 subjects.
Following informed consent, patients with a confirmed diagnosis of Crohn’s disease are recruited into the study as 'probands' or index cases. Each proband is asked to provide information about their healthy siblings or offspring, who will be contacted and asked to participate as subjects. Following informed consent, each subject will attend two visits and will be asked to provide blood samples for genetic analysis, urine and stool samples, as well as answering a series of questions about their environmental exposures and dietary habits. Subjects will be contacted every 6 months for a maximum of 6 years by telephone for a brief health review. If a subject is diagnosed with Crohn's disease they will be asked to consent to repeat the baseline samples and questionnaires as a 'case'. Subjects that do not develop Crohn's disease may also be invited to repeat the baseline samples and questionnaires as a healthy 'control'. Within GEM, data and samples from each case will be compared to four controls.
Lay summary of study results: Summary of the study for the United Kingdom:
Currently for the GEM project we have recruited 5122 subjects in the cohort across all our sites.
In total we have recruited 506 subjects from 36 of our UK sites. Of the 506, 169 have withdrawn due to various reasons. The sites that recruited the most were Western General Hospital in Edinburgh with 53 adult subjects and Addenbrooke's in Cambridge with 37 paediatric subjects. Although recruitment has ended and the UK sites are now closed, analysis and biannual follow-ups continue with the subjects at other international sites. In terms of new diagnoses, only one subject has recently been diagnosed with Crohn’s Disease so far of the 99 new diagnoses from all our sites worldwide.
The study data will be analysed when a sufficient number of new diagnoses have been reached. A summary of the study's results will be included on the GEM project website (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DouFFm-2FZqrUn2jjUD5TieZGooiUhvzlMQim41HPz3q4Haz1-2B-2BIfcfrJDNGLFze5T1xXvw_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKDmaX-2FYOazqOXHpFG4vQSHZZgSNJJFUORf3v-2B3IPZWrI4q6-2B9-2FJBmlBgIX-2FKIrHK1HrrRF-2FCe-2BtRUxp7zH0pg8VVzfQROwA2tNw3UhJKA6Wh24aOkD7HmblOy9NArNKyCv-2FDD3MZk2kKWQr2EN4B-2BQ0s4OSJVjlJHyhPicmsHQMQ-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C2ae02ee13cbe4eaae20608d9e261427c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637789729614851690%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=QAzTmZzC5lrz%2Bb9vLFVnze8pwIjxXts2Qcu%2BFUgV%2B8Q%3D&reserved=0 when available. Research teams at sites may also share summaries of the results when available with participants.REC name
West of Scotland REC 4
REC reference
14/WS/1027
Date of REC Opinion
10 Jul 2014
REC opinion
Favourable Opinion