PRIMAGE (Probiotics, Immunity and Ageing)

NCT01066377 | Unknown

• 1 other identifier: BB/H00470X/1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza

Keywords

prebiotic; probiotic; influenza; vaccination; ageing; immunosenescence

Outcome Measures

Primary Outcomes (1)

• The immune response to influenza vaccination among young and older adults

  Serum vaccine-specific antibodies to the 2010-2011 influenza vaccine will be measured by hemagglutination assay.

  4 weeks after vaccination

Secondary Outcomes (5)

• The cellular and molecular basis for modulation of immune function by pre- and probiotics.

  Assessed after 4 weeks of pre- and probiotic treatment

• The cellular and molecular basis for modulation of immune function by pre- and probiotics.

  Assessed after 6 weeks of pre- and probiotic treatment

• The cellular and molecular basis for modulation of immune function by pre- and probiotics.

  Assessed after 8 weeks of pre- and probiotic treatment

• The modulation of the gut microbiota by pre- and probiotics.

  Assessed after 4 weeks of pre- and probiotic treatment

• The modulation of the gut microbiota by pre- and probiotics.

  Assessed after 8 weeks of pre- and probiotic treatment

Study Arms (2)

Prebiotic and probiotic mix

EXPERIMENTAL

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

Maltodextrin/milk powder

PLACEBO COMPARATOR

Dietary Supplement: Prebiotic and probiotic mix

Interventions

Prebiotic and probiotic mix DIETARY_SUPPLEMENT

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).

Also known as: Bifidobacterium lactentis, Bifidobacterium liberorum, Bifidobacterium infantis, Bifidobacterium longum infantis, Bifidobacterium longum subsp. infantis, oligofructose, oligofructan, oligogalactosyllactose, oligogalactose, oligolactose, transgalactooligosacchariden

Maltodextrin/milk powder; Prebiotic and probiotic mix

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

University of Reading

Reading, RG6 6AP, United Kingdom

Location

Related Publications (3)

• Przemska-Kosicka A, Childs CE, Maidens C, Dong H, Todd S, Gosney MA, Tuohy KM, Yaqoob P. Age-Related Changes in the Natural Killer Cell Response to Seasonal Influenza Vaccination Are Not Influenced by a Synbiotic: a Randomised Controlled Trial. Front Immunol. 2018 Mar 22;9:591. doi: 10.3389/fimmu.2018.00591. eCollection 2018.

  PMID: 29662493 DERIVED

• Enani S, Przemska-Kosicka A, Childs CE, Maidens C, Dong H, Conterno L, Tuohy K, Todd S, Gosney M, Yaqoob P. Impact of ageing and a synbiotic on the immune response to seasonal influenza vaccination; a randomised controlled trial. Clin Nutr. 2018 Apr;37(2):443-451. doi: 10.1016/j.clnu.2017.01.011. Epub 2017 Jan 28.

  PMID: 28215759 DERIVED

• Przemska-Kosicka A, Childs CE, Enani S, Maidens C, Dong H, Dayel IB, Tuohy K, Todd S, Gosney MA, Yaqoob P. Effect of a synbiotic on the response to seasonal influenza vaccination is strongly influenced by degree of immunosenescence. Immun Ageing. 2016 Mar 15;13:6. doi: 10.1186/s12979-016-0061-4. eCollection 2016.

  PMID: 26985232 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Prebiotics; oligofructose

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Parveen Yaqoob

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: January 1, 2013
• Last Updated: July 13, 2011

Record last verified: 2011-07

Locations

GB (1)