Immune Function in Offsprings of Females With Inflammatory Bowel Disease

Sheba Medical Center

Status: Completed

Conditions: Inflammatory Bowel Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02079441

SHEBA-13-0613-BW-CTIL

Details and patient eligibility

About

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

Full description

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

Enrollment: 24 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

Infants, IBD, anti TNF, pregnancy

Description:

Infants of mothers with anti-TNF in pregnancy

infants, IBD, pregnancy, medications

Description:

Infants of mothers with non anti TNFin pregnancy