Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy
|ClinicalTrials.gov Identifier: NCT02079441|
Recruitment Status : Unknown
Verified March 2014 by Batia Weiss, Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
- To evaluate the immune response to vaccines in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of IBD mother not treated with anti-TNF medications.
- To evaluate the immune function of B and T cells at 3 months and one year of age in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of non anti-TNF treated mothers.
The secondary aims are to follow anti TNF drug levels in infants born to IBD patients treated with anti-TNF medications during pregnancy and to evaluate the risk of infections during the first year of life in this population, compared to children of IBD patients not treated with anti-TNF medications during pregnancy.
Significance -The results of this study have the potential to change clinical practice of anti TNF treatment during pregnancy and the follow-up of infants born to these patients
|Condition or disease|
|Inflammatory Bowel Disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||February 2017|
Infants, IBD mothers, anti TNF, pregnancy
Infants born to mother with IBD receiving ant- TNF medications during pregnancy
infants, IBD mothers, pregnancy, medications
Infants born to mothers with IBD receiving non anti TNF medications during pregnancy
- Antibodies to vaccine agents at age 12 months. 2. Immunoglobulin levels, B and T cell production (IgG subclasses, T cell subpopulation numbers) and function (response to mitogens and antigens) at age 3 months and 1 year [ Time Frame: 12 months ]
- Anti TNF drug level in cord blood [ Time Frame: birth ]
- Infection number and type during the first year of life [ Time Frame: 12 months ]
- Antibiotic use in the first year [ Time Frame: 12 months ]
- Breast feeding influence (with and without additional medications) on the immune function of the children [ Time Frame: 12 months ]
Biospecimen Retention: Samples Without DNA