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.
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)
Show all 13Show fewer
- 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.
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 group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Prebiotic | Experimental | Inulin type fructooligosaccharides Receives: Dietary Supplement: Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum anti-vaccine antibody concentrations
Measured: Weeks 2 and 4 post-vaccination
Secondary outcomes (7)
Serum total antibody (IgG, IgA, IgM) concentrations
Measured: Weeks -4, 0, 2 and 4 with respect to vaccination
Innate immune responses - neutrophil and monocyte phagocytosis and respiratory burst
Measured: Weeks -4, 0, 2 and 4 with respect to vaccination
Ex vivo T lymphocyte responses to mitogen (activation, proliferation and cytokine production)
Measured: Weeks -4, 0, 2 and 4 with respect to vaccination
Ex vivo T lymphocyte responses to vaccine (activation, proliferation and cytokine production)
Measured: Weeks 0, 2 and 4 with respect to vaccination
Ex vivo natural killer cell activity
Measured: Weeks -4, 0, 2 and 4 with respect to vaccination
Faecal microflora
Measured: Weeks -4 and 0 with respect to vaccination
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.
- First posted12 May 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Sponsor
- Investigators
- Philip C Calder, PhD, Principal investigator, University of Southampton
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of a Prebiotic Supplement on Immune Function in Healthy Human Adults
- ClinicalTrials.gov ID
- NCT00898599
- Acronym / sponsor ID
- RHMNUT0055
- Conditions
- Immune Function
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Placebo |
| Prebiotic | Experimental | Dietary Supplement: PrebioticInulin type fructooligosaccharides |
Who may qualify
- Ages
- 45 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticAlso: Synergy1Inulin type fructooligosaccharides | Dietary supplement | Prebiotic |
| PlaceboAlso: MaltodextrinMaltodextrin as placebo | Dietary supplement | Maltodextrin |
Primary outcome
Serum anti-vaccine antibody concentrations
Time frame: Weeks 2 and 4 post-vaccination
7 secondary outcomes
Serum total antibody (IgG, IgA, IgM) concentrations
Time frame: Weeks -4, 0, 2 and 4 with respect to vaccination
Innate immune responses - neutrophil and monocyte phagocytosis and respiratory burst
Time frame: Weeks -4, 0, 2 and 4 with respect to vaccination
Ex vivo T lymphocyte responses to mitogen (activation, proliferation and cytokine production)
Time frame: Weeks -4, 0, 2 and 4 with respect to vaccination
Ex vivo T lymphocyte responses to vaccine (activation, proliferation and cytokine production)
Time frame: Weeks 0, 2 and 4 with respect to vaccination
Ex vivo natural killer cell activity
Time frame: Weeks -4, 0, 2 and 4 with respect to vaccination
Faecal microflora
Time frame: Weeks -4 and 0 with respect to vaccination
Salivary IgA concentration
Time frame: Weeks -4, 0, 2 and 4 with respect to vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip C Calder, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
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.