Immune Function in Offsprings of Females With Inflammator... | NCT02079441

Studies
Immune Function in Offsprings of Females With Inflammatory Bowel Disease

NCT02079441

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Jul 5, 2024Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Inflammatory Bowel Disease

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Feb 2019Actual

Completion Date

Feb 2019Actual

First Submitted Date

Feb 27, 2014

First Submission Date that Met QC Criteria

Mar 4, 2014

First Posted Date

Mar 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Batia Weiss, Director, Pediatric Gastroenterology and Nutrition Unit, Sheba Medical CenterPrincipal Investigator

Lead Sponsor

Sheba Medical CenterOTHER_GOV

Collaborators

Name	Class
Schneider Children's Hospital	OTHER
Tel Aviv Medical Center	OTHER
Shaare Zedek Medical Center	OTHER
Assaf-Harofeh Medical Center

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.
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

Detailed Description

1. 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba_Medical Center		Ramat Gan		52625	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided