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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
Sponsor:
Information provided by:
University of Reading

Study Description
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Brief Summary:
The aim of the study is to investigate the effect of dietary supplements such as probiotic, prebiotic and synbiotic on the immune response to influenza vaccination and faecal microbiota in adult healthy volunteers.

Condition or disease Intervention/treatment Phase
Dietary Intervention Dietary Supplement: probiotic Dietary Supplement: prebiotic Dietary Supplement: Synbiotic Dietary Supplement: Placebo Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed consent form
  • 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:

  • Evidence of physical or mental disease or planned major surgery, which might limit participation in or completion of the study
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Maria Magdalena Baran, MSc 0044118 378 6217 m.m.baran@reading.ac.uk

Locations
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United Kingdom
University of Reading, Food and Nutritional Sciences Department
Reading, Berkshire, United Kingdom, RG66AP
Principal Investigator: Maria Magdalena Baran, MSc         
Sponsors and Collaborators
University of Reading
Investigators
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Principal Investigator: Maria Magdalena Baran, MSc
Principal Investigator: Sofia Kolida, PhD
More Information
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Responsible Party: Magdalena Baran, University of Reading
ClinicalTrials.gov Identifier: NCT01084434    
Other Study ID Numbers: F3168407
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: February 2010