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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Sheba Medical Center
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
ClinicalTrials.gov Identifier:
NCT02079441
First received: February 27, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose
  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
Inflammatory Bowel Disease

Study Type: Observational
Study Design: 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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti TNF drug level in cord blood [ Time Frame: birth ] [ Designated as safety issue: No ]
  • Infection number and type during the first year of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Antibiotic use in the first year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Breast feeding influence (with and without additional medications) on the immune function of the children [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood tests


Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: February 27, 2014
Last Updated: March 4, 2014
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 14, 2014