Clinical trial NCT02079441: Immune Function in Offsprings of Females With Inflammatory Bowel Disease
Official title: Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Keywords: Anti- TNF
inflammatory bowel disease
pregnancy
infant
immunity
Immune function
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Schneider Children's Hospital
name: Tel Aviv Medical Center
name: Shaare Zedek Medical Center
name: Assaf-Harofeh Medical Center
name: Rambam Health Care Campus
First posted: 2014-03-05
Enrollment: 24
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a multicenter prospective controlled trial. The study population includes infants born to mothers with IBD, divided into two groups: Study group- infants of IBD patients treated with anti-TNF during pregnancy. Control group- infants of IBD patients treated with non-anti TNF medications during pregnancy.

Brief summary: 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Anti TNF drug level in cord blood
timeFrame: birth
measure: Infection number and type during the first year of life
timeFrame: 12 months
measure: Antibiotic use in the first year
timeFrame: 12 months
measure: Breast feeding influence (with and without additional medications) on the immune function of the children
timeFrame: 12 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba_Medical Center
Study officials:
References: