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OpenTrials
Completed

NCT Number: NCT02079441

Immune Function in Offsprings of Females With Inflammatory Bowel Disease

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

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheba_Medical Center

Ramat Gan, 52625, Israel

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children born to mothers with IBD who were treated with ant-TNF medications, other medications or not medically treated for IBD during pregnancy .
  • 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.
  • Inform consent signed by the parents.

Exclusion criteria

  • Children with intrauterine or perinatal infections, congenital diseases or malformations.
  • Absence of immunization records.
  • Known immune deficiency of mother and/or child. 4. Mothers with hepatitis B

Treatment and study plan

Primary outcomes

  1. 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

  1. Anti TNF drug level in cord blood

    Time frame: birth

  2. Infection number and type during the first year of life

    Time frame: 12 months

  3. Antibiotic use in the first year

    Time frame: 12 months

  4. Breast feeding influence (with and without additional medications) on the immune function of the children

    Time frame: 12 months

    Not performed

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Assaf-Harofeh Medical Center
  • Rambam Health Care Campus
  • Schneider Children's Hospital
  • Shaare Zedek Medical Center
  • Tel Aviv Medical Center

Registry information

Official study title

Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2014
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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