The gut microbiome changes profoundly during pregnancy in healthy women. We hypothesize these microbiome changes will also occur in pregnant IBD women and can possibly have clinical implications.
ID
Bron
Verkorte titel
Aandoening
Inflammatory bowel disease
Pregnancy
Gut microbiome
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- to analyze the gut microbiome of IBD patients during pregnancy; can the changes during pregnancy in the gut microbiome be linked to disease activity/flares.
Achtergrond van het onderzoek
Crohn’s disease and ulcerative colitis, collectively referred to as inflammatory bowel disease (IBD), are chronic, relapsing diseases. The exact etiology remains unknown, however, it is currently believed to be a complex interaction between genetic susceptibility, gut microbiota, the host immune response and environmental factors(1). IBD typically arises at a young, fertile age, as 50% of patients will be younger than 35 years old when the diagnosis is established(2). Therefore, reproductive issues are of important concern for both the IBD patients and their treating physicians. Preconception counseling in these patients remains challenging, as many complex questions can only be answered with limited, mainly retrospective and sometimes conflicting data. In addition, most of the (registry based) cohorts are outdated(3-10), not including the most recent therapies for IBD like anti-TNF, which have become a mainstay in IBD treatment over the last decade(11). Obviously, the need for an up-to-date, properly conducted, prospective cohort is long overdue. We therefore propose to conduct a prospective cohort study in IBD females with a pregnancy wish and pregnant IBD females, to gather data on IBD characteristics during pregnancy and the effect of pregnancy on IBD. Furthermore, as a recent study has shown pregnancy to influence gut microbiota in non IBD patients(12), we also propose to investigate whether the gut microbiome in IBD patients changes during pregnancy and whether these changes have any clinical implications.
Doel van het onderzoek
The gut microbiome changes profoundly during pregnancy in healthy women. We hypothesize these microbiome changes will also occur in pregnant IBD women and can possibly have clinical implications.
Onderzoeksopzet
Visit 1: before pregnancy (when patient expresses a pregnancy wish)
Visit 2: First trimester (gestational week 10)
Visit 3: Second trimester (gestational week 20)
Visit 4: Third trimester (gestational week 30)
1 year after delivery: retrospectively obtain health data on th child via General Practitioner
Onderzoeksproduct en/of interventie
No interventions
4 visits (1 before pregnancy, and 1 in each trimester) to obtain blood samples, fecal samples and questionnaires
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Female
- Age 18-43
- Confirmed diagnosis of CD, UC or IBDu, by endoscopy and/or pathology
- Pregnancy wish
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Incapacity to understand pre-conceptional counseling, informed consent and/or questionnaire (e.g. language barrier, no interpreter)
- Diabetes mellitus
- Infection with HIV, HBV or HCV
- Substance abuse (chronic hard drug use, alcoholism, shorter than 2 years clean)
- Other auto-immune diseases
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL4426 |
NTR-old | NTR4550 |
Ander register | NL 47357.078.13 : MEC-2013-579 |