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

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ClinicalTrials.gov Identifier: NCT02079441
Recruitment Status : Unknown
Verified March 2014 by Batia Weiss, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Collaborators:
Schneider Children's Hospital
Tel Aviv Medical Center
Shaare Zedek Medical Center
Assaf-Harofeh Medical Center
Rambam Health Care Campus
Information provided by (Responsible Party):
Batia Weiss, Sheba Medical Center

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


Condition or disease
Inflammatory Bowel Disease

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy
Study Start Date : March 2014
Estimated Primary Completion Date : February 2017

Group/Cohort
Infants, IBD mothers, anti TNF, pregnancy
Infants born to mother with IBD receiving ant- TNF medications during pregnancy
infants, IBD mothers, pregnancy, medications
Infants born to mothers with IBD receiving non anti TNF medications during pregnancy



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
Blood tests


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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Responsible Party: Batia Weiss, Director, Pediatric Gastroenterology and Nutrition Unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02079441     History of Changes
Other Study ID Numbers: SHEBA-13-0613-BW-CTIL
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Batia Weiss, Sheba Medical Center:
Anti- TNF
inflammatory bowel disease
pregnancy
infant
immunity
Immune function

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis