Immune Function in Offsprings of Females With Inflammatory Bowel Disease

NCT02079441 | Completed

• 1 other identifier: SHEBA-13-0613-BW-CTIL
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Inflammatory Bowel Disease

Keywords

Anti- TNF; inflammatory bowel disease; pregnancy; infant; immunity; Immune function

Outcome Measures

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

  12 months

Secondary Outcomes (4)

• Anti TNF drug level in cord blood

  birth

• Infection number and type during the first year of life

  12 months

• Antibiotic use in the first year

  12 months

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

  12 months

Study Arms (2)

Infants, IBD, anti TNF, pregnancy

Infants of mothers with anti-TNF in pregnancy

infants, IBD, pregnancy, medications

Infants of mothers with non anti TNFin pregnancy

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sheba_Medical Center

Ramat Gan, 52625, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood tests

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology and Nutrition Unit

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 5, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: July 5, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)