ImmunityNCT00645996
The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
A study testing Probiotics (L.acidophilus and B.lactis) and Cornflor in people with Immunity and Measles, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Background: It is well established that the presence of bacteria in the intestine has a profound influence on health. Probiotics, ("beneficial bacteria") have shown ameliorating effects on various infectious diseases. Read more about this study
- Who is it for?
- Ages 9 to 14 monthsHealthy volunteers can take part
- What is being tested?
- Probiotics (L.acidophilus and B.lactis) and Cornflor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Oct 2009
- Phase
- Interventional
- 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 9 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 9-11 months.
- Parent or guardian intending to follow the recommended immunization schedule in Israel.
- Parent or guardian possessing sufficient knowledge of the Hebrew language.
Who cannot join
- Infants suffering from any chronic diseases / conditions resulting in immune depression.
- Infants taking medications affecting the immune system.
- Infants with permanent invasive catheters.
- Infants born prematurely (prior to gestational week 35)
- Parent or guardian objecting to collection of blood sample at the end of study.
Trial locations and contacts
1 site in 1 country.
Ilan Youngster, MD contact
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Tsrifin
Ilan Youngster
About this study
Background: It is well established that the presence of bacteria in the intestine has a profound influence on health. Probiotics, ("beneficial bacteria") have shown ameliorating effects on various infectious diseases. The influence of probiotics on several immune-mediated conditions has also been investigated, among them, atopic dermatitis ("Asthma of the skin"), and milk allergy.
The precise mechanism of action of probiotics is not fully understood. Several animal and human studies have shown the probiotic bacteria to influence the immune system. The aim of the present study is to evaluate whether supplementing the diet with oral probiotics affects the immune response of children following routine vaccination against 4 common childhood viral diseases: Mumps, Measles, Rubella and Varicella.
Read more
Objective(s) and Hypothesis(es):
Hypothesis: Administration of probiotics will increase the amount of antibodies produced following vaccination for Measles, Mumps, Rubella and Varicella, by over 15%.
Objectives:
- To determine whether administration of probiotics during infancy influences antibody levels following the routine childhood vaccinations.
- To determine whether administration of probiotics during infancy influences the rate of adverse effects following the routine childhood vaccinations.
Potential Impact: Vaccines, alongside with the discovery of Penicillin, have been cited as the great public health successes of the 20th century. However, even in countries with maximal childhood immunization coverage, the protective effect is not optimal. For example, only 70% to 90% of children immunized against chickenpox are actually protected against the disease. If we succeed in raising these numbers, even by a single percent, it will have a huge impact on society.
- Being tested
- Probiotics (L.acidophilus and B.lactis), Cornflor
- Keywords
- Probiotics, vaccines, Measles, Mumps, Rubella
- Medical subject headings
- Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (L.acidophilus and B.lactis)Dietary supplement
2.1 X 109 L.acidophilus and B.lactis
CornflorDietary supplement
Cornflour 2 gram daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Probiotics (L.acidophilus and B.lactis) |
| 2 | Placebo comparator | Cornflour Receives: Dietary Supplement: Cornflor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.
Measured: 1 year
Secondary outcomes (1)
The number of vaccine-related adverse events in the study group compared to the placebo group.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Eran Kozer, Principal investigator, Assaf Harofeh MCIlan Youngster, MD, Principal investigator, Assaf Harofeh MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645996
- Sponsor's protocol ID
- 20070567(101/07)
- Status last verified
- Mar 2008
- First submitted
- 25 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
- ClinicalTrials.gov ID
- NCT00645996
- Acronym / sponsor ID
- 20070567(101/07)
- Keywords
- Probiotics, vaccines, Measles, Mumps, Rubella
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 28 Mar 2008 (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.
Background: It is well established that the presence of bacteria in the intestine has a profound influence on health. Probiotics, ("beneficial bacteria") have shown ameliorating effects on various infectious diseases. The influence of probiotics on several immune-mediated conditions has also been investigated, among them, atopic dermatitis ("Asthma of the skin"), and milk allergy.
The precise mechanism of action of probiotics is not fully understood. Several animal and human studies have shown the probiotic bacteria to influence the immune system. The aim of the present study is to evaluate whether supplementing the diet with oral probiotics affects the immune response of children following routine vaccination against 4 common childhood viral diseases: Mumps, Measles, Rubella and Varicella.
Objective(s) and Hypothesis(es):
Hypothesis: Administration of probiotics will increase the amount of antibodies produced following vaccination for Measles, Mumps, Rubella and Varicella, by over 15%.
Objectives:
- To determine whether administration of probiotics during infancy influences antibody levels following the routine childhood vaccinations.
- To determine whether administration of probiotics during infancy influences the rate of adverse effects following the routine childhood vaccinations.
Potential Impact: Vaccines, alongside with the discovery of Penicillin, have been cited as the great public health successes of the 20th century. However, even in countries with maximal childhood immunization coverage, the protective effect is not optimal. For example, only 70% to 90% of children immunized against chickenpox are actually protected against the disease. If we succeed in raising these numbers, even by a single percent, it will have a huge impact on society.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Probiotics (L.acidophilus and B.lactis) |
| 2 | Placebo comparator | Dietary Supplement: CornflorCornflour |
Who may qualify
- Ages
- 9 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 9-11 months.
- Parent or guardian intending to follow the recommended immunization schedule in Israel.
- Parent or guardian possessing sufficient knowledge of the Hebrew language.
Key exclusion criteria (5 listed)
- Infants suffering from any chronic diseases / conditions resulting in immune depression.
- Infants taking medications affecting the immune system.
- Infants with permanent invasive catheters.
- Infants born prematurely (prior to gestational week 35)
- Parent or guardian objecting to collection of blood sample at the end of study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics (L.acidophilus and B.lactis)2.1 X 109 L.acidophilus and B.lactis | Dietary supplement | 1 |
| CornflorCornflour 2 gram daily | Dietary supplement | 2 |
Primary outcome
The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.
Time frame: 1 year
1 secondary outcome
The number of vaccine-related adverse events in the study group compared to the placebo group.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2008.
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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.
Ilan Youngster, MD contact
Eran Kozer principal investigator
Assaf Harofeh MC
Ilan Youngster, MD principal investigator
Assaf Harofeh MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics (L.acidophilus and B.lactis) and Cornflor in people with Immunity and Measles, run by Assaf-Harofeh 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 5 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: status not confirmed, as of the sponsor's last update on 28 Mar 2008. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Youngster, MD (972-8-9779130), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group. (time frame: 1 year). 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 28 Mar 2008.