Dietary InterventionNCT01084434
Probiotic, Prebiotic and Synbiotic Effect on Immunity
A study testing probiotic, prebiotic and Synbiotic in people with Dietary Intervention, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Intervention
- What is being tested?
- probiotic, prebiotic and Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to Jun 2011
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Reading, Food and Nutritional Sciences Department
Reading, Berkshire, RG66AP
Maria Magdalena Baran, MSc
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Dietary Intervention
- Being tested
- probiotic, prebiotic, Synbiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticDietary supplement
Also called HOWARU Bifidobacterium lactis
Bifidobacterium lactis HN019 10^9 CFU/day 1 sachet once a day for 7 weeks
prebioticDietary supplement
Also called Bimuno
Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks
SynbioticDietary supplement
(Bifidobacterium lactis 10^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks
PlaceboDietary supplement
Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Group of 25 volunteers consuming probiotic product once a day for 7 weeks Receives: Dietary Supplement: probiotic |
| Prebiotic group | Experimental | Group of 25 volunteers consuming prebiotic product once a day for 7 weeks Receives: Dietary Supplement: prebiotic |
| Synbiotic group | Experimental | Group of 25 volunteers consuming synbiotic product once a day for 7 weeks. Receives: Dietary Supplement: Synbiotic |
| Placebo group | Placebo comparator | Group of 25 volunteers consuming placebo product once a day for 7 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome would be a higher change in antibody levels in response to influenza vaccination compared to placebo group.
Measured: 2 and 4 weeks after vaccination
Secondary outcomes (1)
The secondary outcome would be a change in faecal microbiota groups and a change in their metabolic activities.
Measured: at 0, 7 and 10 weeks on pro-, pre,synbiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary InterventionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Investigators
- Maria Magdalena Baran, MSc, Principal investigatorSofia Kolida, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084434
- Sponsor's protocol ID
- F3168407
- Status last verified
- Feb 2010
- First submitted
- 18 Feb 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01084434
- Acronym / sponsor ID
- F3168407
- Conditions
- Dietary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 10 Mar 2010 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: probioticGroup of 25 volunteers consuming probiotic product once a day for 7 weeks |
| Prebiotic group | Experimental | Dietary Supplement: prebioticGroup of 25 volunteers consuming prebiotic product once a day for 7 weeks |
| Synbiotic group | Experimental | Dietary Supplement: SynbioticGroup of 25 volunteers consuming synbiotic product once a day for 7 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboGroup of 25 volunteers consuming placebo product once a day for 7 weeks |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| probioticAlso: HOWARU Bifidobacterium lactisBifidobacterium lactis HN019 10^9 CFU/day 1 sachet once a day for 7 weeks | Dietary supplement | Probiotic group |
| prebioticAlso: BimunoGalactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks | Dietary supplement | Prebiotic group |
| Synbiotic(Bifidobacterium lactis 10^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks | Dietary supplement | Synbiotic group |
| PlaceboMaltodextrin 5.5g/day - 1 sachet once a day for 7 weeks | Dietary supplement | Placebo group |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
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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.
Maria Magdalena Baran, MSc principal investigator
Sofia Kolida, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic, prebiotic and Synbiotic in people with Dietary Intervention, run by University of Reading 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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 10 Mar 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Magdalena Baran, MSc (0044118 378 6217, m.m.baran@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 10 Mar 2010; AzTrials last refreshed its copy on 29 Oct 2026.