Immune Function in Offsprings of Females With Inflammatory Bowel Disease

N/ACompletedNCT02079441

Sheba Medical Center24 enrolled

Overview

1. 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. 2. 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

1\. We aim 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. 2 WE aim 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. Our 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. 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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Inflammatory Bowel Disease

Medical Language ↔ Plain English

Inclusion Criteria: 1. Children born to mothers with IBD who were treated with ant-TNF medications, other medications or not medically treated for IBD during pregnancy . 2. Regular vaccination for hepatitis B at birth, 1 and 6 months of age and other scheduled non-live vaccines at 2,4, and 6 months of age. 3. Inform consent signed by the parents. Exclusion Criteria: 1. Children with intrauterine or perinatal infections, congenital diseases or malformations. 2. Absence of immunization records. 3. Known immune deficiency of mother and/or child. 4. Mothers with hepatitis B

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Not performed

Time frame: 12 months

Immune Function in Offsprings of Females With Inflammatory Bowel Disease

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes