InflammationNCT05529693
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
A study testing Experimental: Bif-038 arm, high dose and Experimental: Bif-038 arm, low dose in people with Inflammation, run by Chr Hansen at 1 site in Ireland.
Trial summary
To investigate the effectiveness of two doses of the probiotic strain Bif-038 on markers of low-grade inflammation in a elderly population Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Experimental: Bif-038 arm, high dose and Experimental: Bif-038 arm, low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteIreland
- Study dates
- 29 Sep 2022to 1 Dec 2023
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in the study and comply with its procedures
- Able to give written informed consent
- Healthy adults as determined by the investigator
- Age: ≥ 60 years and ≤ 85 years
- hs-CRP: 2.0-10.0 mg/L
- BMI: 18.5-32 kg/m2
- Temperature between ≥35.5 and ≤37.3oC
- A stable body weight (≤5 % change) over the 3 months prior to screening.
Who cannot join
- Cold or flu-like (URTI) symptoms, with a Jackson Cold Scale score of >2; not otherwise explained by seasonal allergies
- Chronic disease such as, cardiovascular diseases, gastrointestinal disorders, and rheumatoid arthritis, which in the Investigators judgment, precludes involvement in the study
- Oral antibiotics within 4 weeks prior to the screening visit
- Use of immunosuppressant drugs, systemic steroids or systemic antimicrobial medication (including suppositories) within the 4 weeks prior to the screening visit
- Regular oral non-steroidal anti-inflammatory medication use (1 week) (topical NSAIDS allowed). Low-dose prophylactic aspirin use is acceptable if stable for 9 months prior to screening.
- Uncontrolled, unstable hypertension at the discretion of the investigator.
Show all 19Show fewer
- Current smoking, chewable tobacco and/or vaping. Low dose (<50mg/week) nicotine products allowed.
- Planned change in current diet or exercise habits
- Habitual intake of probiotic supplements within 2 months before screening visit
- Have had gastrointestinal surgery (e.g. colectomy, cholecystectomy, gastric bypass); Appendectomy allowed. Laparoscopic surgeries (removal of polyps, cysts) are allowed.
- Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results;
- Any change in medication or supplement intake in the 30 days prior to baseline
- Any major dietary changes in the 30 days prior to baseline
- Has a history of drug and/or alcohol abuse at the time of enrolment;
- Has received treatment involving experimental drugs in 2 months prior to screening
- Any immunosuppressant or chemotherapy medications, including marcaptopurine, azothioprine, or methotrexate;
- Use of herbal remedies and supplements with potential anti-inflammatory properties for the duration of the study, which in the Investigators judgement may have an impact on the objectives of the study.
- Have a current malignant disease or any current concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study;
- Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population - a Randomized, Double-blind, Placebo-controlled, Parallel Group Pilot Study With 12 Weeks Intervention
To investigate the effectiveness of two doses of the probiotic strain Bif-038 on markers of low-grade inflammation in a elderly population
Read the detailed description
The study is a randomized, double-blind, 3-arm, placebo-controlled pilot study in an elderly population (60-85 years) with low-grade inflammation (hs-CRP 2-10 mg/L) comparing two doses daily intake of Bif-038 at 1 and 10 billion CFU to placebo for 12 weeks. The subjects will receive either one of the two test products or the placebo product daily for a period of 12 weeks.
During the entire study period, five visits are scheduled. The subjects will participate in two screening visits; a baseline visit, a visit after 6 weeks of intervention and an end-of-study visit after 12 weeks of intervention. Visit 1 and 2 are screening- and recruitment visits with at least two weeks apart. Only participants with a hs-CRP within 2.0-10.0 mg/L will be invited for the second screening visit. Participants with repeated hs-CRP levels within 2.0-10.0 mg/L will be invited for baseline visit 3, to be included and randomized in the study.
At the screening visits the eligibility will be checked after the participants have given their written informed consent.
Blood samples and stool samples will be collected during the study and subjects will be asked to complete questionnaires and a dietary diary.
No sample size calculations were performed due to the exploratory nature of a pilot study design. Planned number to include is 20 subjects per study arm, thus 60 subjects in total.
- Conditions
- Inflammation
- Being tested
- Experimental: Bif-038 arm, high dose, Experimental: Bif-038 arm, low dose, Placebo Comparator: Placebo arm
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Bif-038 arm, high doseDietary supplement
Also called Probiotic
Active trial product with minimum 10 billion CFU daily dose
Experimental: Bif-038 arm, low doseDietary supplement
Also called Probiotic
Active trial product with minimum 1 billion CFU daily dose
Placebo Comparator: Placebo armDietary supplement
Also called Placebo
Similar product to trial product but without Bif-038
| Study group | Role | What they receive |
|---|---|---|
| Bif-038 arm, high dose | Experimental | Active trial product with minimum 10 billion CFU daily dose Receives: Dietary Supplement: Experimental: Bif-038 arm, high dose |
| Bif-038 arm, low dose | Experimental | Active trial product with minimum 1 billion CFU daily dose Receives: Dietary Supplement: Experimental: Bif-038 arm, low dose |
| Placebo arm | Placebo comparator | Similar trial product, but without Bif-038 probiotic bacteria Receives: Dietary Supplement: Placebo Comparator: Placebo arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs-CRP
The effect of daily intake of Bif-038 10 billion CFU versus placebo on hs-CRP
Measured: 12 weeks
Secondary outcomes (1)
TNF-alfa
The effect of daily intake of Bif-038 10 billion CFU versus placebo on TNF-alfa
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start29 Sep 2022
- Primary completion30 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, Professor, Principal investigator, Atlantia Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529693
- Sponsor's protocol ID
- HND-IM-047
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population - a Randomized, Double-blind, Placebo-controlled, Parallel Group Pilot Study With 12 Weeks Intervention
- ClinicalTrials.gov ID
- NCT05529693
- Acronym / sponsor ID
- HND-IM-047
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- 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.
To investigate the effectiveness of two doses of the probiotic strain Bif-038 on markers of low-grade inflammation in a elderly population
Detailed description
The study is a randomized, double-blind, 3-arm, placebo-controlled pilot study in an elderly population (60-85 years) with low-grade inflammation (hs-CRP 2-10 mg/L) comparing two doses daily intake of Bif-038 at 1 and 10 billion CFU to placebo for 12 weeks. The subjects will receive either one of the two test products or the placebo product daily for a period of 12 weeks.
During the entire study period, five visits are scheduled. The subjects will participate in two screening visits; a baseline visit, a visit after 6 weeks of intervention and an end-of-study visit after 12 weeks of intervention. Visit 1 and 2 are screening- and recruitment visits with at least two weeks apart. Only participants with a hs-CRP within 2.0-10.0 mg/L will be invited for the second screening visit. Participants with repeated hs-CRP levels within 2.0-10.0 mg/L will be invited for baseline visit 3, to be included and randomized in the study.
At the screening visits the eligibility will be checked after the participants have given their written informed consent.
Blood samples and stool samples will be collected during the study and subjects will be asked to complete questionnaires and a dietary diary.
No sample size calculations were performed due to the exploratory nature of a pilot study design. Planned number to include is 20 subjects per study arm, thus 60 subjects in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bif-038 arm, high dose | Experimental | Dietary Supplement: Experimental: Bif-038 arm, high doseActive trial product with minimum 10 billion CFU daily dose |
| Bif-038 arm, low dose | Experimental | Dietary Supplement: Experimental: Bif-038 arm, low doseActive trial product with minimum 1 billion CFU daily dose |
| Placebo arm | Placebo comparator | Dietary Supplement: Placebo Comparator: Placebo armSimilar trial product, but without Bif-038 probiotic bacteria |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing to participate in the study and comply with its procedures
- Able to give written informed consent
- Healthy adults as determined by the investigator
- Age: ≥ 60 years and ≤ 85 years
- hs-CRP: 2.0-10.0 mg/L
Key exclusion criteria (19 listed)
- Cold or flu-like (URTI) symptoms, with a Jackson Cold Scale score of >2; not otherwise explained by seasonal allergies
- Chronic disease such as, cardiovascular diseases, gastrointestinal disorders, and rheumatoid arthritis, which in the Investigators judgment, precludes involvement in the study
- Oral antibiotics within 4 weeks prior to the screening visit
- Use of immunosuppressant drugs, systemic steroids or systemic antimicrobial medication (including suppositories) within the 4 weeks prior to the screening visit
- Regular oral non-steroidal anti-inflammatory medication use (1 week) (topical NSAIDS allowed). Low-dose prophylactic aspirin use is acceptable if stable for 9 months prior to screening.
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 |
|---|---|---|
| Experimental: Bif-038 arm, high doseAlso: ProbioticActive trial product with minimum 10 billion CFU daily dose | Dietary supplement | Bif-038 arm, high dose |
| Experimental: Bif-038 arm, low doseAlso: ProbioticActive trial product with minimum 1 billion CFU daily dose | Dietary supplement | Bif-038 arm, low dose |
| Placebo Comparator: Placebo armAlso: PlaceboSimilar product to trial product but without Bif-038 | Dietary supplement | Placebo arm |
Primary outcome
hs-CRP
Time frame: 12 weeks
The effect of daily intake of Bif-038 10 billion CFU versus placebo on hs-CRP
1 secondary outcome
TNF-alfa
Time frame: 12 weeks
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 4 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
Timothy Dinan, Professor principal investigator
Atlantia Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Bif-038 arm, high dose and Experimental: Bif-038 arm, low dose in people with Inflammation, run by Chr Hansen at 1 site in Ireland.
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 19 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 4 Dec 2023. 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 Ireland. 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?
hs-CRP (time frame: 12 weeks). 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 4 Dec 2023.