No registrations found.
ID
Source
Brief title
Health condition
inflammatory bowel disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Gut microbiome changes over the course of pregnancy (before pregnancy, T1, T2 and T3 after delivery and and at least 3 months after delivery) in terms of diversity, taxonomic changes and richness
- Gut microbiome changes in children from IBD mothers in terms of diversity, taxonomic changes and richness compared to a historical cohort
- Disease activity during pregnancy as measured by clinical activity scores (Harvey Bradshaw Index for CD and Simplified Clinical Colitis Activity Index), laboratory findings and/or endoscopy findings.
Secondary outcome
Birth outcomes
Birth weight
Gestational term
Congenital abnormalities
Mode of delivery
APGAR scores at 1 minute and 5 minutes
- Child health data:
o Number of infections that required antibiotics
o Hospital admissions
o Growth
o Reactions to vaccinations
o Allergies
Background summary
Prospective follow up of the natural history of pregnant IBD patients. In order to provide patients with appropriate pre-conceptional counseling regarding their disease in combination with pregnancy, more research needs to be done on this subject. We therefore aim to describe the natural history of IBD during and after pregnancy, investigate the gut microbiome at several time points during and after pregnancy and eventually assess the health and microbiome of the children born to IBD mothers in comparison to children of healthy mothers.
Study objective
Studies have described an altered bacterial diversity in the gut of women with IBD as compared to healthy controls. Infants born to mothers with IBD have shown to have lower diversity and altered gut microbiome at least until age 3 months. This might be important since prenatal and early life microbiome is thought to influence the development of the immune system. Whether this altered gut microbiome remains in women after pregnancy and in infants beyond age 3 months is unclear. We will perform follow up on the gut microbiome of women who previously in the study participated and their children beyond 3 months of age.
Study design
women: first, second and third trimester of pregnancy, after delivery and and at least 3 months after delivery
children: at least 3 months after birth
Intervention
not applicable
Jantien Bolt-Wieringa
088 979 7900
j.wieringa@erasmusmc.nl
Jantien Bolt-Wieringa
088 979 7900
j.wieringa@erasmusmc.nl
Inclusion criteria
- Female
- Age 18-43
- Confirmed diagnosis of CD, UC or IBDu, by endoscopy and/or pathology
o For the retrospective part of the study:
Visited the pre-conception outpatient clinic after IBD diagnosis between January 2008 and December 2013 before pregnancy
Visited the pre-conception outpatient clinic after IBD diagnosis between January 2008 and December 2013 for the first time during pregnancy
- children of participating women
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8418 |
| CCMO | NL47357.078.13 |
| OMON | NL-OMON50661 |