ImmunosenescenceEarly Phase 1PRIMESNCT01303484
The Effect of Prebiotic B-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People
A Early Phase 1 study testing Bi2muno® GOS and Maltodextrin in people with Immunosenescence, run by Clasado at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunosenescence
- What is being tested?
- Bi2muno® GOS and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Jul 2014
- Phase
- Early Phase 1
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged between 65 and 80 years of age.
- In good general health
- The volunteer has given written informed consent to participate and is willing to participate in the entire study.
Who cannot join
- History or evidence of disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.
- Family history of colorectal cancer in under 50's
- Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
- Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study (please note sensory evaluations are still permitted).
- Undergone surgical resection of any part of the bowel.
- History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
Show all 14Show fewer
- Smoker
- Lactose intolerant
- Allergic to gluten
- Currently prescribed immunosuppressive drugs. Participants will be required to withdraw should they begin taking any of the ineligible medication.
- Intention to use regularly other medication which affects gastrointestinal motility and/or perception.
- History of alcohol or drug misuse.
- Suffer from any major conditions involving the following:
- Head, Ears, Eyes, Nose and Throat Dermatological/Connective tissue Coeliac disease Neurological Lymphatic Urogenital/Rectal Gastroenterological Abdominal Respiratory Cardiovascular Incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo Controlled Cross- Over Study to Determine the Effect of prebioticB-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People
The purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people
- Conditions
- Immunosenescence
- Being tested
- Bi2muno® GOS, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi2muno® GOSDietary supplement
Also called galactooligosaccharide
5.5g/day for 10 weeks
MaltodextrinDietary supplement
Also called Dextrin
5.5g daily for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| MDn | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Maltodextrin |
| B-GOS | Active comparator | Prebiotic Receives: Dietary Supplement: Bi2muno® GOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers
Measured: 12 months
Effect of B-GOS on the faecal microbiota composition of elderly persons
Measured: 12 months
Effect of aging on body metabolites using NMR
Measured: 12 months
Secondary outcomes (2)
Effect of B-GOS on gut permeability
Measured: 12 months
Weekly assessment of stools and gastrointestinal symptoms
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosenescenceStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clasado
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Reading
- Responsible party
- Sponsor
- Investigators
- Glenn Gibson, PhD, Principal investigator, University of Reading, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303484
- Sponsor's protocol ID
- Clasado2011
- Acronym
- PRIMES
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2011
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled Cross- Over Study to Determine the Effect of prebioticB-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People
- ClinicalTrials.gov ID
- NCT01303484
- Acronym / sponsor ID
- PRIMES / Clasado2011
- Conditions
- Immunosenescence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ClasadoIndustry (pharma, biotech, devices)
- Collaborators
- University of Reading
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Feb 2011 (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 purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDn | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin |
| B-GOS | Active comparator | Dietary Supplement: Bi2muno® GOSPrebiotic |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged between 65 and 80 years of age.
- In good general health
- The volunteer has given written informed consent to participate and is willing to participate in the entire study.
Key exclusion criteria (14 listed)
- History or evidence of disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.
- Family history of colorectal cancer in under 50's
- Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
- Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study (please note sensory evaluations are still permitted).
- Undergone surgical resection of any part of the bowel.
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 |
|---|---|---|
| Bi2muno® GOSAlso: galactooligosaccharide5.5g/day for 10 weeks | Dietary supplement | B-GOS |
| MaltodextrinAlso: Dextrin5.5g daily for 10 weeks | Dietary supplement | MDn |
Primary outcome
Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers
Time frame: 12 months
Effect of B-GOS on the faecal microbiota composition of elderly persons
Time frame: 12 months
Effect of aging on body metabolites using NMR
Time frame: 12 months
2 secondary outcomes
Effect of B-GOS on gut permeability
Time frame: 12 months
Weekly assessment of stools and gastrointestinal symptoms
Time frame: 8 months
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 25 Mar 2016.
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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.
Glenn Gibson, PhD principal investigator
University of Reading, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bi2muno® GOS and Maltodextrin in people with Immunosenescence, run by Clasado 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 3 inclusion and 14 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 25 Mar 2016. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers (time frame: 12 months). The study lists 3 primary outcomes in all. 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 25 Mar 2016.