Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2010-05-31
2011-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probiotic group
Group of 25 volunteers consuming probiotic product once a day for 7 weeks
probiotic
Bifidobacterium lactis HN019 10\^9 CFU/day 1 sachet once a day for 7 weeks
Prebiotic group
Group of 25 volunteers consuming prebiotic product once a day for 7 weeks
prebiotic
Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks
Synbiotic group
Group of 25 volunteers consuming synbiotic product once a day for 7 weeks.
Synbiotic
(Bifidobacterium lactis 10\^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks
Placebo group
Group of 25 volunteers consuming placebo product once a day for 7 weeks
Placebo
Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks
Interventions
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probiotic
Bifidobacterium lactis HN019 10\^9 CFU/day 1 sachet once a day for 7 weeks
prebiotic
Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks
Synbiotic
(Bifidobacterium lactis 10\^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks
Placebo
Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 40-65 years
* Body mass index 18.5-30 inclusive
* Good general health as determined by medical questionnaires
* Not vaccinated with the current seasonal influenza (2009) or swine flu vaccine
Exclusion Criteria
* History of drug misuse, including alcohol
* Allergy to the vaccine
* Asplenia and other acquired or congenital immunodeficiency
* Severe allergy such as asthma, hay-fever, dermatitis or being treated on these
* History of severe abnormal drug reaction
* Any autoimmune disease
* Diabetic (type 1 or type2)
* Food allergy manifested by gastrointestinal, skin, respiratory , neurological, anaphylaxis symptoms
* Lactose intolerance showed by clinical symptoms such as nausea, cramping, bloating, diarrhea and flatulence after consuming lactose containing dairy products (milk, yoghurt, butter, cheese, ice-cream, sour cream) or lactose non-dairy products ( whey, milk solids, modified milk ingredients)
* Participation in experimental drug trial within four weeks prior to study
* Participation in prebiotics or laxative trial within the previous three months
* Use of antibiotics within the previous six months
* Chronic constipation, diarrhoea or other chronic gastro-intestinal complaint
* Intake of other prebiotics or probiotics, drugs active on gastrointestinal motility, or a laxative of any class for four weeks prior to study
* Use of prescribed medication
* Regular use of aspirin or other anti-inflammatory drugs
45 Years
65 Years
ALL
Yes
Sponsors
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University of Reading
OTHER
Responsible Party
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University of Reading
Principal Investigators
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Maria Magdalena Baran, MSc
Role: PRINCIPAL_INVESTIGATOR
Sofia Kolida, PhD
Role: PRINCIPAL_INVESTIGATOR
Locations
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University of Reading, Food and Nutritional Sciences Department
Reading, Berkshire, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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F3168407
Identifier Type: -
Identifier Source: org_study_id
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