PRIMAGE (Probiotics, Immunity and Ageing)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Reading
Information provided by:
University of Reading
ClinicalTrials.gov Identifier:
NCT01066377
First received: February 9, 2010
Last updated: July 12, 2011
Last verified: July 2011
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Purpose
Ageing dramatically affects immune function; this phenomenon is known as immunosenescence and partly explains the increased susceptibility for infection in older individuals. Vaccination is recommended to protect older people against influenza, but immunosenescence also reduces the efficacy of vaccination. Probiotics are beneficial bacteria, which can be consumed and which have a long and safe record of use in humans. Often they are taken together with prebiotics, which are carbohydrates that provide a food source for the beneficial bacteria when they reach the lower gut. There is particular interest in the positive influences of pre- and probiotics in older people, who are subject to alteration in gut microflora composition as well as immunosenescence.
The PRIMAGE (Probiotics, immunity and ageing) study will examine the effect of a prebiotic and probiotic mix on the immune response to influenza vaccination in young and older subjects, and is funded by BBSRC DRINC. It will involve 60 young (18-35y) and 60 older (65-85y) subjects recruited from the local Reading community. Participants will take a pre- and probiotic mixture or a placebo for a total of 8 weeks. The probiotic is not currently commercially produced, but has been demonstrated to have particular ecological fitness and anti-pathogenic effects in the gastrointestinal tract in old age. A suitable prebiotic will be selected on the basis of ability to promote optimal growth and survival of this probiotic. After 4 weeks on the treatment, the subjects will receive an influenza vaccination. Blood, saliva and stool samples will be taken before treatment, and at 4, 6 and 8 weeks after commencement. The samples taken at 6 and 8 weeks will be used to assess the immune response to the vaccination. A wide range of immune parameters will be assessed, taking into account the age-related shifts in immune cell populations.
| Condition | Intervention |
|---|---|
|
Influenza |
Dietary Supplement: Prebiotic and probiotic mix |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) |
| Official Title: | A Randomised, Controlled, Parallel Study to Determine the Immunomodulatory Effects of Pre- and Probiotics Upon the Immune Response to Influenza Vaccination in Young and Older Volunteers |
Resource links provided by NLM:
Further study details as provided by University of Reading:
Primary Outcome Measures:
- The immune response to influenza vaccination among young and older adults [ Time Frame: 4 weeks after vaccination ] [ Designated as safety issue: No ]Serum vaccine-specific antibodies to the 2010-2011 influenza vaccine will be measured by hemagglutination assay.
Secondary Outcome Measures:
- The cellular and molecular basis for modulation of immune function by pre- and probiotics. [ Time Frame: Assessed after 4 weeks of pre- and probiotic treatment ] [ Designated as safety issue: No ]Blood samples will be subject to density gradient separation of peripheral blood mononuclear cells (PBMC), and cryopreserved for NK cell analysis, cell phenotypes, cytokine production, proliferation, expression of activation markers, expression of toll like receptors and assessment of T cell receptor excision circles (TREC). Serum and plasma will be stored for measurement of chemokines, plasma lipids and glucose. Saliva samples will be used to assess salivary IgA content.
- The cellular and molecular basis for modulation of immune function by pre- and probiotics. [ Time Frame: Assessed after 6 weeks of pre- and probiotic treatment ] [ Designated as safety issue: No ]Blood samples will be subject to density gradient separation of peripheral blood mononuclear cells (PBMC), and cryopreserved for NK cell analysis, cell phenotypes, cytokine production, proliferation, expression of activation markers, expression of toll like receptors and assessment of T cell receptor excision circles (TREC). Serum and plasma will be stored for measurement of chemokines, plasma lipids and glucose. Saliva samples will be used to assess salivary IgA content.
- The cellular and molecular basis for modulation of immune function by pre- and probiotics. [ Time Frame: Assessed after 8 weeks of pre- and probiotic treatment ] [ Designated as safety issue: No ]Blood samples will be subject to density gradient separation of peripheral blood mononuclear cells (PBMC), and cryopreserved for NK cell analysis, cell phenotypes, cytokine production, proliferation, expression of activation markers, expression of toll like receptors and assessment of T cell receptor excision circles (TREC). Serum and plasma will be stored for measurement of chemokines, plasma lipids and glucose. Saliva samples will be used to assess salivary IgA content.
- The modulation of the gut microbiota by pre- and probiotics. [ Time Frame: Assessed after 4 weeks of pre- and probiotic treatment ] [ Designated as safety issue: No ]Faecal samples will be processed for later analysis by fluorescence in situ hybridization (FISH) using oligonucleotide 16s rRNA probes targeting dominant and important groups of gut bacteria. Denatured gradient gel electrophoresis (DGGE) will be used to assess changes in faecal bacterial abundance and species diversity. qPCR will be used to identify specific bacterial species, including Bifidobacterium longum. Faecal dry weight and IgA content will be assessed. Faecal content of microbial metabolites such as short chain fatty acids and ammonia will be quantified.
- The modulation of the gut microbiota by pre- and probiotics. [ Time Frame: Assessed after 8 weeks of pre- and probiotic treatment ] [ Designated as safety issue: No ]Faecal samples will be processed for later analysis by fluorescence in situ hybridization (FISH) using oligonucleotide 16s rRNA probes targeting dominant and important groups of gut bacteria. Denatured gradient gel electrophoresis (DGGE) will be used to assess changes in faecal bacterial abundance and species diversity. qPCR will be used to identify specific bacterial species, including Bifidobacterium longum. Faecal dry weight and IgA content will be assessed. Faecal content of microbial metabolites such as short chain fatty acids and ammonia will be quantified.
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | January 2013 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prebiotic and probiotic mix
Prebiotic: 8g/day, will be selected on the basis of ability to promote optimal growth and survival of the probiotic (inulin, fructooligosaccharides [FOS], galactooligosaccharides[GOS] and xylooligosaccharides[XOS] will be tested). Probiotic: 10^8 - 10^9 live bacteria/day, bifidobacterium longum bv. infantis CCUG52486.
|
Dietary Supplement: Prebiotic and probiotic mix
The probiotic strain will be Bifidobacterium longum bv. infantis CCUG 52486 (10^8 - 10^9 live bacteria per day), which was originally isolated from healthy elderly subjects, and which has been demonstrated to have particular ecological fitness and anti-pathogenic effects in vitro. A suitable prebiotic (8g/day) will be selected on the basis of ability to promote optimal growth and survival of this probiotic (inulin, fructooligosaccharides [FOS], galactooligosaccharides[GOS] and xylooligosaccharides[XOS] will be tested).
Other Names:
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| Placebo Comparator: Maltodextrin/milk powder |
Dietary Supplement: Prebiotic and probiotic mix
The probiotic strain will be Bifidobacterium longum bv. infantis CCUG 52486 (10^8 - 10^9 live bacteria per day), which was originally isolated from healthy elderly subjects, and which has been demonstrated to have particular ecological fitness and anti-pathogenic effects in vitro. A suitable prebiotic (8g/day) will be selected on the basis of ability to promote optimal growth and survival of this probiotic (inulin, fructooligosaccharides [FOS], galactooligosaccharides[GOS] and xylooligosaccharides[XOS] will be tested).
Other Names:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Suitable study participants will be defined as:
- aged 18-35 (young cohort) or 65-85 (older cohort) men and women
- BMI 18.5 - 30 kg/m2
- good general health as determined by medical questionnaires and laboratory data from screening blood and urine sample (fasting glucose, ESR, FBC, liver function tests, renal profile, dipstick urinalysis)
- not pregnant, lactating or planning a pregnancy
Exclusion Criteria:
- allergy to the influenza vaccine
- HIV infection
- diabetes requiring any medication
- asplenia and other acquired or congenital immunodeficiencies
- any autoimmune disease
- malignancy
- cirrhosis
- connective tissue diseases
- current use of immunomodulating medication (including oral prednisone and inhaled steroids)
- self-reported symptoms of acute or recent infection (including use of antibiotics within last 3 months)
- taking lactulose or any other treatment for constipation
- alcoholism and drug misuse
Additional exclusion criteria for older volunteers includes:
- laboratory data which is outside the normal range for this age group AND outside the ranges specified in the SENIEUR protocol for ESR, FBC, renal profile, liver function tests, fasting glucose and dipstick urinalysis (Ligthart et al, 1984)
- Barthel Index score of <16
- CIRS score of <15.
Additional exclusion criteria for younger volunteers is:
- laboratory data which is outside the normal range
- influenza vaccination in the previous 12 months.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr Mike Proven, University of Reading |
| ClinicalTrials.gov Identifier: | NCT01066377 History of Changes |
| Other Study ID Numbers: | BB/H00470X/1 |
| Study First Received: | February 9, 2010 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Reading:
|
prebiotic probiotic influenza |
vaccination ageing immunosenescence |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Sulfalene Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 16, 2013