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Immune FunctionPhase 1/2NCT00898599

Prebiotics and Immune Function in Middle Aged Humans

A Phase 1/2 study testing Prebiotic in people with Immune Function, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented by some species of intestinal bacteria. Read more about this study

Who is it for?
Ages 45 to 66 yearsHealthy volunteers can take part
Conditions the study is for
Immune Function
What is being tested?
Prebiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2009to Jul 2010
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 66 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 45-65 years
  • Body mass index 20 to 32 kg/m2.
  • Not consuming probiotic supplements, yoghurts, drinks or other foods
  • Not consuming prebiotic supplemented drinks or foods
  • In general good health
  • No antibiotic use in the 2 months prior to entering the study or during the study
  • Not been vaccinated with the current season's influenza vaccine
  • Being able to provide written informed consent

Who cannot join

  • Aged < 45 or > 66 years
  • Body mass index < 20 or > 32 kg/m2.
  • Being diabetic (type 1 or type 2)
  • Displaying manifestations of allergy - asthma, hay-fever, dermatitis - or being treated for these
  • Being egg allergic
  • Use of any prescribed medicine (unless deemed to be acceptable by the PI)
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  • Suffering from any infectious illness
  • Chronic gastrointestinal problems (e.g. IBD, IBS, cancer)
  • Recent blood donation
  • Participation in another clinical trial
  • Use of prebiotic or probiotic supplements, foods or drinks
  • Consuming vitamin, mineral or oil supplements
  • Previously vaccinated with the influenza vaccine being used.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Southampton

    Southampton, SO16 6YD

Other trials in United Kingdom

About this study

Official title: Investigation of the Effects of a Prebiotic Supplement on Immune Function in Healthy Human Adults

Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented by some species of intestinal bacteria. This fermentation is thought to have several benefits for the host including improving immune function. There are numerous methods available for assessing the human immune response. Response to vaccination is thought to be a good method for this. Not many studies have examined the effect of prebiotics on the human immune response to vaccination. Thus the investigators propose to test the effect of a prebiotic on the immune response in healthy volunteers including their response to the current flu vaccine. The investigators hypothesise that the prebiotic will enhance the immune response including the response to the vaccine.

Read the detailed description

Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented by some species of intestinal bacteria. This fermentation is thought to have several benefits for the host including improving the immune response. Inulin-type fructans (oligofructose and inulin) are classified as prebiotics. Inulin is found naturally in significant amounts in a variety of plants foods, such as bananas, leeks, onions, artichokes, wheat and chicory. Synergy1 is a prebiotic preparation produced by Beneo-Orafti, and containing a mixture of oligofructose and inulin derived from chicory. Fructooligosaccharides including Synergy1 are widely used by the food industry and are commonly found as a source of insoluble fibre in many biscuit, bakery, cereal and dairy products.

There is increasing evidence that the changes in the intestinal microflora that occur with the consumption of fructooligosaccharides can modulate immune parameters, not only in the gut-associated lymphoid tissue, but also secondary lymphoid tissues and the peripheral circulation. Much of the evidence for beneficial effects of fructooligosaccharides on immune function comes from animal models e.g. rats, mice, dogs and pigs. Results from these studies show that the innate and adaptive immune systems of both the gut associated lymphoid tissue and the systemic immune system can be modified by fructooligosaccharides. However, there are few human studies so far which have investigated the effects of prebiotics on immune function, and these studies mostly rely on systemic markers of immunity. The results show little effect of fructooligosaccharides on innate immune function, but mixed results are reported regarding the adaptive immune system, suggesting that there may by improvement on this aspect of immunity with increased intake of fructooligosaccharides. The small number of published human studies led Watzl et al. (2005) to suggest that more human studies are needed to find out whether inulin and/or oligofructose have the potential to modulate systemic immunity in well-nourished individuals.

There are numerous methods available for assessing the human immune response. These have been evaluated by a panel of European experts (Albers et al. 2005). Based on its biological relevance, sensitivity and practical feasibility, response to vaccination was identified by this panel as the gold standard for measuring the functioning of the immune system in vivo (Albers et al. 2005). A small number of studies have studied the effect of fructooligosaccharides on the human immune response using vaccination response as the outcome, but only four of these examined fructooligosaccharides in the absence of other additional nutrients and of these two studies were in infants. Thus, the number of studies examining the immunologic impact of fructooligosaccharides in adult humans and using the gold standard outcome is very limited. From a public health perspective, it would be of importance, if fructooligosaccharides can improve immune function especially in older adults who are at risk of age-related immune decline. Thus, we propose to use a commercially available influenza vaccine (Imuvac®) to stimulate the immune response in healthy human adults, and to use this to assess the effect of a well defined prebiotic preparation commonly used in the food industry (Synergy1).

Conditions
Immune Function
Being tested
Prebiotic, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrebioticDietary supplement

    Also called Synergy1

    Inulin type fructooligosaccharides

  • PlaceboDietary supplement

    Also called Maltodextrin

    Maltodextrin as placebo

Study groups in NCT00898599
Study groupRoleWhat they receive
MaltodextrinPlacebo comparatorNot described
Receives: Dietary Supplement: Placebo
PrebioticExperimentalInulin type fructooligosaccharides
Receives: Dietary Supplement: Prebiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum anti-vaccine antibody concentrations

    Measured: Weeks 2 and 4 post-vaccination

Secondary outcomes (7)
  1. Serum total antibody (IgG, IgA, IgM) concentrations

    Measured: Weeks -4, 0, 2 and 4 with respect to vaccination

  2. Innate immune responses - neutrophil and monocyte phagocytosis and respiratory burst

    Measured: Weeks -4, 0, 2 and 4 with respect to vaccination

  3. Ex vivo T lymphocyte responses to mitogen (activation, proliferation and cytokine production)

    Measured: Weeks -4, 0, 2 and 4 with respect to vaccination

  4. Ex vivo T lymphocyte responses to vaccine (activation, proliferation and cytokine production)

    Measured: Weeks 0, 2 and 4 with respect to vaccination

  5. Ex vivo natural killer cell activity

    Measured: Weeks -4, 0, 2 and 4 with respect to vaccination

  6. Faecal microflora

    Measured: Weeks -4 and 0 with respect to vaccination

  7. Salivary IgA concentration

    Measured: Weeks -4, 0, 2 and 4 with respect to vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2009
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00898599
Sponsor's protocol ID
RHMNUT0055
Status last verified
Jul 2010
First submitted
20 Apr 2009
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Prebiotic in people with Immune Function, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum anti-vaccine antibody concentrations (time frame: Weeks 2 and 4 post-vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

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