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Immune Function in Offsprings of Females With Inflammatory Bowel Disease

NCT02079441 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2024-07-05

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Schneider Children's Hospital

    collaborator OTHER

  • Tel Aviv Medical Center

    collaborator OTHER

  • Shaare Zedek Medical Center

    collaborator OTHER

  • Assaf-Harofeh Medical Center

    collaborator OTHER_GOV

  • Rambam Health Care Campus

    collaborator OTHER

  • Sheba Medical Center

    lead OTHER_GOV

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02079441 on ClinicalTrials.gov