Inflammatory Bowel DiseaseNCT02079441
Immune Function in Offsprings of Females With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy
- 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
Read the detailed description
- 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
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Anti- TNF, inflammatory bowel disease, pregnancy, infant, immunity, Immune function
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (4)
Anti TNF drug level in cord blood
Measured: birth
Infection number and type during the first year of life
Measured: 12 months
Antibiotic use in the first year
Measured: 12 months
Breast feeding influence (with and without additional medications) on the immune function of the children
Not performed
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Schneider Children's Hospital, Tel Aviv Medical Center, Shaare Zedek Medical Center, Assaf-Harofeh Medical Center, Rambam Health Care Campus
- Responsible party
- Principal investigator, Batia Weiss, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079441
- Sponsor's protocol ID
- SHEBA-13-0613-BW-CTIL
- Status last verified
- May 2022
- First submitted
- 27 Feb 2014
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Function in Offsprings of Females With Inflammatory Bowel Disease (IBD) Treated With Anti-TNF Medications During Pregnancy
- ClinicalTrials.gov ID
- NCT02079441
- Acronym / sponsor ID
- SHEBA-13-0613-BW-CTIL
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Anti- TNF, inflammatory bowel disease, pregnancy, infant, immunity, Immune function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Schneider Children's Hospital, Tel Aviv Medical Center, Shaare Zedek Medical Center, Assaf-Harofeh Medical Center, Rambam Health Care Campus
- Study start
- Mar 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Anti TNF drug level in cord blood
Time frame: birth
Infection number and type during the first year of life
Time frame: 12 months
Antibiotic use in the first year
Time frame: 12 months
Breast feeding influence (with and without additional medications) on the immune function of the children
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.