Low-grade InflammationNCT02342496
Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly
A study testing Active, only probiotics and Active, blend of berries and probiotics in people with Low-grade Inflammation and Increased Intestinal Permeability, run by Probi AB at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the ability of a blend of berries and probiotics in reducing low-grade inflammation and intestinal permeability in the elderly. The intervention period is one month. Read more about this study
- Who is it for?
- Ages 75 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-grade Inflammation, Increased Intestinal Permeability
- What is being tested?
- Active, only probiotics and Active, blend of berries and probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2015to 4 Dec 2015
- 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 75 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age >75 years
- CRP 2-10 mg/L
- Ability to fill in a study diary by him/herself
Who cannot join
- Intake of antibiotic treatment in the last 4 weeks before inclusion into the study.
- Currently on corticosteroid treatment
- Presence of chronic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly.
The purpose of this study is to evaluate the ability of a blend of berries and probiotics in reducing low-grade inflammation and intestinal permeability in the elderly. The intervention period is one month. Blood and fecal samples will be collected for analysis at baseline and at the end of the intervention with the aim to analyse possible changes in different parameters at the two timepoints. The participants will also be asked to keep a study diary throughout the study period for the documentation of their intestinal health and as a means for checking compliance.
- Being tested
- Placebo, Active, only probiotics, Active, blend of berries and probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Powder
Active, only probioticsDietary supplement
Powder
Active, blend of berries and probioticsDietary supplement
Powder
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Powder consisting of maltodextrine, treated to resemble the Active product in appearance and taste. Receives: Dietary Supplement: Placebo |
| Active, only probiotics | Active comparator | Powder consisting of freezedried bacteria at 10 billions cfu/daily dose and maltodextrine, treated to resemble the Active product in appearance and taste. Receives: Dietary Supplement: Active, only probiotics |
| Active, blend of berries and probiotics | Active comparator | Powder consisting of freezedried berries , probiotics at 10 billions cfu/daily dose and maltodextrine. Receives: Dietary Supplement: Active, blend of berries and probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced intestinal permebility measured as decline in the levels of zonulin in blood samples
Measured: All blood markers analysed in the study will be measured at start, before the onset of intervention and 4 weeks later at the end of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completion4 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low-grade InflammationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342496
- Sponsor's protocol ID
- 2014/3
- Status last verified
- Apr 2018
- First submitted
- 18 Dec 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
Publications
Lazou-Ahren I, Bjorklund M, Molin G, Xu J, Onning G, Elmstahl S, Jeppsson B. Probiotic-Reduced Inflammaging in Older Adults: A Randomized, Double-Blind, Placebo-Controlled Trial. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3429-3439. doi: 10.1007/s12602-024-10310-7. Epub 2024 Jun 19.
PubMed 38896223
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly.
- ClinicalTrials.gov ID
- NCT02342496
- Acronym / sponsor ID
- 2014/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- 4 Dec 2015 (actual)
- First posted
- 21 Jan 2015 (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 evaluate the ability of a blend of berries and probiotics in reducing low-grade inflammation and intestinal permeability in the elderly. The intervention period is one month. Blood and fecal samples will be collected for analysis at baseline and at the end of the intervention with the aim to analyse possible changes in different parameters at the two timepoints. The participants will also be asked to keep a study diary throughout the study period for the documentation of their intestinal health and as a means for checking compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPowder consisting of maltodextrine, treated to resemble the Active product in appearance and taste. |
| Active, only probiotics | Active comparator | Dietary Supplement: Active, only probioticsPowder consisting of freezedried bacteria at 10 billions cfu/daily dose and maltodextrine, treated to resemble the Active product in appearance and taste. |
| Active, blend of berries and probiotics | Active comparator | Dietary Supplement: Active, blend of berries and probioticsPowder consisting of freezedried berries , probiotics at 10 billions cfu/daily dose and maltodextrine. |
Who may qualify
- Ages
- 75 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age >75 years
- CRP 2-10 mg/L
- Ability to fill in a study diary by him/herself
Key exclusion criteria (3 listed)
- Intake of antibiotic treatment in the last 4 weeks before inclusion into the study.
- Currently on corticosteroid treatment
- Presence of chronic inflammatory disease
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 |
|---|---|---|
| PlaceboPowder | Dietary supplement | Placebo |
| Active, only probioticsPowder | Dietary supplement | Active, only probiotics |
| Active, blend of berries and probioticsPowder | Dietary supplement | Active, blend of berries and probiotics |
Primary outcome
Reduced intestinal permebility measured as decline in the levels of zonulin in blood samples
Time frame: All blood markers analysed in the study will be measured at start, before the onset of intervention and 4 weeks later at the end of intervention.
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 17 Apr 2018.
- Derived from this study: PubMed 38896223Lazou-Ahren I, Bjorklund M, Molin G, Xu J, Onning G, Elmstahl S, Jeppsson B. Probiotic-Reduced Inflammaging in Older Adults: A Randomized, Double-Blind, Placebo-Controlled Trial. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3429-3439. doi: 10.1007/s12602-024-10310-7. Epub 2024 Jun 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active, only probiotics and Active, blend of berries and probiotics in people with Low-grade Inflammation and Increased Intestinal Permeability, run by Probi AB at 1 site in Sweden.
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 3 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 17 Apr 2018. 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 Sweden. 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?
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?
Reduced intestinal permebility measured as decline in the levels of zonulin in blood samples (time frame: All blood markers analysed in the study will be measured at start, before the onset of intervention and 4 weeks later at the end of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342496, which also lists 1 linked publication.
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 17 Apr 2018.