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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

Tracking Information
First Submitted Date  ICMJE February 18, 2010
First Posted Date  ICMJE March 10, 2010
Last Update Posted Date March 10, 2010
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotic, Prebiotic and Synbiotic Effect on Immunity
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dietary Intervention
Intervention  ICMJE
  • Dietary Supplement: probiotic
    Bifidobacterium lactis HN019 10^9 CFU/day 1 sachet once a day for 7 weeks
    Other Name: HOWARU Bifidobacterium lactis
  • Dietary Supplement: prebiotic
    Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks
    Other Name: Bimuno
  • Dietary Supplement: Synbiotic
    (Bifidobacterium lactis 10^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks
  • Dietary Supplement: Placebo
    Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks
Study Arms  ICMJE
  • Experimental: Probiotic group
    Group of 25 volunteers consuming probiotic product once a day for 7 weeks
    Intervention: Dietary Supplement: probiotic
  • Experimental: Prebiotic group
    Group of 25 volunteers consuming prebiotic product once a day for 7 weeks
    Intervention: Dietary Supplement: prebiotic
  • Experimental: Synbiotic group
    Group of 25 volunteers consuming synbiotic product once a day for 7 weeks.
    Intervention: Dietary Supplement: Synbiotic
  • Placebo Comparator: Placebo group
    Group of 25 volunteers consuming placebo product once a day for 7 weeks
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 9, 2010)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01084434
Other Study ID Numbers  ICMJE F3168407
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Magdalena Baran, University of Reading
Study Sponsor  ICMJE University of Reading
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria Magdalena Baran, MSc
Principal Investigator: Sofia Kolida, PhD
PRS Account University of Reading
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP