The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
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| ClinicalTrials.gov Identifier: NCT00645996 |
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Recruitment Status : Unknown
Verified March 2008 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Immunity Measles Mumps Rubella | Dietary Supplement: Probiotics (L.acidophilus and B.lactis) Dietary Supplement: Cornflor | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Study Start Date : | March 2008 |
| Estimated Primary Completion Date : | July 2009 |
| Estimated Study Completion Date : | October 2009 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Dietary Supplement: Probiotics (L.acidophilus and B.lactis)
2.1 X 109 L.acidophilus and B.lactis |
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Placebo Comparator: 2
Cornflour
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Dietary Supplement: Cornflor
Cornflour 2 gram daily |
- The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group. [ Time Frame: 1 year ]
- The number of vaccine-related adverse events in the study group compared to the placebo group. [ Time Frame: 1 year ]
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| Ages Eligible for Study: | 9 Months to 14 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645996
| Contact: Ilan Youngster, MD | 972-8-9779130 |
| Israel | |
| Assaf Harofeh Medical Center | Recruiting |
| Zerifin, Israel | |
| Principal Investigator: Ilan Youngster | |
| Principal Investigator: | Eran Kozer | Assaf Harofeh MC | |
| Principal Investigator: | Ilan Youngster, MD | Assaf Harofeh MC |
| Responsible Party: | Ilan Youngster, Assaf Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT00645996 History of Changes |
| Other Study ID Numbers: |
20070567(101/07) |
| First Posted: | March 28, 2008 Key Record Dates |
| Last Update Posted: | March 28, 2008 |
| Last Verified: | March 2008 |
Keywords provided by Assaf-Harofeh Medical Center:
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Probiotics vaccines Measles Mumps Rubella |
Additional relevant MeSH terms:
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Measles Rubella Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections |
RNA Virus Infections Virus Diseases Rubivirus Infections Togaviridae Infections |