Probiotic, Prebiotic and Synbiotic Effect on Immunity
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|ClinicalTrials.gov Identifier: NCT01084434|
Recruitment Status : Unknown
Verified February 2010 by University of Reading.
Recruitment status was: Not yet recruiting
First Posted : March 10, 2010
Last Update Posted : March 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Dietary Intervention||Dietary Supplement: probiotic Dietary Supplement: prebiotic Dietary Supplement: Synbiotic Dietary Supplement: Placebo||Not Applicable|
Within recent times, influenza has become a major respiratory infection worldwide. The preventative vaccination reduces the severity of infection but ageing reduced its efficacy and it is only effective in 17-53% in elderly individuals. Thus, nutritionists and medical researchers are looking for opportunities to improve the immune response to influenza vaccine. Functional foods, such as probiotics, prebiotics and synbiotics, apart from other health benefits, may contribute towards immune protection.
Probiotics are beneficial bacteria, which are regarded as safe and serve health benefits to the host, while prebiotics are carbohydrates which by escaping digestion in the upper gastrointestinal tract may reach the colon and there serve as food for beneficial bacteria in the colon. When prebiotic used in combination with probiotic bacteria, it is called synbiotic, and it may improve survival and implantation of probiotic in the gut.
The human study will examine the immune response to vaccination and changes in faecal microbiota during administration of probiotic, prebiotic and synbiotic supplements. The study will be conducted between vaccinations seasons in 2010-2011 and recruit 100 healthy subjects aged 40-65years old. Participant will be given one of four different treatments over a 7 week period following 3 weeks of wash-out period. Treatments given include: a probiotic, a prebiotic, a synbiotic and a placebo. In the 3rd week of product consumption the participant will be given a flu jab. Specific antibody titre against the 3 viral strains composing the vaccine and total immunoglobulin concentration in the serum will be monitored during 2 and 4 weeks after vaccination. Faecal samples and saliva will be collected and analysed for changes in faecal microbial populations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Double-blind, Placebo Controlled Randomized Parallel Study to Determine the Effects of Pre-pro and Synbiotic Administration on the Immune Response to Influenza Vaccination and Faecal Microbiota in Healthy Adults|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||January 2011|
|Estimated Study Completion Date :||June 2011|
Experimental: Probiotic group
Group of 25 volunteers consuming probiotic product once a day for 7 weeks
Dietary Supplement: probiotic
Bifidobacterium lactis HN019 10^9 CFU/day 1 sachet once a day for 7 weeks
Other Name: HOWARU Bifidobacterium lactis
Experimental: Prebiotic group
Group of 25 volunteers consuming prebiotic product once a day for 7 weeks
Dietary Supplement: prebiotic
Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks
Other Name: Bimuno
Experimental: Synbiotic group
Group of 25 volunteers consuming synbiotic product once a day for 7 weeks.
Dietary Supplement: Synbiotic
(Bifidobacterium lactis 10^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks
Placebo Comparator: Placebo group
Group of 25 volunteers consuming placebo product once a day for 7 weeks
Dietary Supplement: Placebo
Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks
- The primary outcome would be a higher change in antibody levels in response to influenza vaccination compared to placebo group. [ Time Frame: 2 and 4 weeks after vaccination ]
- The secondary outcome would be a change in faecal microbiota groups and a change in their metabolic activities. [ Time Frame: at 0, 7 and 10 weeks on pro-, pre,synbiotic treatment ]
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): NCT01084434
|Contact: Maria Magdalena Baran, MSc||0044118 378 firstname.lastname@example.org|
|University of Reading, Food and Nutritional Sciences Department|
|Reading, Berkshire, United Kingdom, RG66AP|
|Principal Investigator: Maria Magdalena Baran, MSc|
|Principal Investigator:||Maria Magdalena Baran, MSc|
|Principal Investigator:||Sofia Kolida, PhD|