VOLUNTEERSPhase 4NCT02622867
Lactobacillus Plantarum 3547 Effects Over Inflammatory and Immunologic Markers
A Phase 4 study testing Lactobacillus plantarum 3547 and Maltodextrin in people with VOLUNTEERS, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effects of the probiotic Lactobacillus plantarum 3547 over different inflammation and immune system markers on a healthy middle-aged group. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- VOLUNTEERS
- What is being tested?
- Lactobacillus plantarum 3547 and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Dec 2013
- Phase
- Phase 4
- 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
- Men and women from 45 to 65 years old;
- Body Mass Index (BMI) ≥ 18,5 and < 40 kg/m2
- Signed informed consent.
- Adequate cultural level and understanding for the clinical trial.
- Free of infections at baseline
Who cannot join
- Individuals with severe diseases (hepatic, kidney, cancer…);
- Individuals with diagnosed metabolic syndrome, diabetes and/or hyperthyroidism;
- Individuals with chronic intestinal pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohn's disease…);
- Individuals with dementia, mental disease or low cognitive function;
- Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or immunosuppressants;
- Individuals with major surgeries during the last month or gastrointestinal surgery in the last 3 months;
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- Individuals treated with oral antibiotics during two weeks prior to the beginning of the study;
- Individuals undergoing dietary restriction and/or pharmacological treatment for the decrease of body weight 2 months prior to the beginning of the study;
- Individuals who intend to quit smoking during the next 20 weeks;
- Women that consume oral contraceptive;
- Pregnant women or breastfeeding;
- Individuals with intensive physical activity (> 2 hours, more than 3 times per week);
- Individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics during the 2 weeks prior to the beginning of the study and that will not eliminate their consumption during the study;
- Individuals with regular consumption (> 3 servings per week) of fermented foods (yogurt, actimel, kefir, blue cheese…) and/or use of other prebiotics and not to accept suppress their consumption during the study;
- Individuals with increased alcohol consumption >30g/day (equivalent to 300 ml of wine, about 3 beers or a cup (75 ml) of whiskey , brandy , anise, etc);
- Individuals with regular use of laxatives (> 2 a week) and (Laxbene, Miralax, Dulco - Lax, etc.) and does not accept suppress its consumption during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Intervention Clinical Trial to Evaluate the Lactobacillus Plantarum 3547 Probiotic Effects Over Different Inflammation and Immune System Markers in a Group of Healthy Middle-aged People
The purpose of this study is to evaluate the effects of the probiotic Lactobacillus plantarum 3547 over different inflammation and immune system markers on a healthy middle-aged group.
Read the detailed description
In this randomized double blind controlled trial, a group of healthy middle-aged people (45 to 65 years old) had a nutritional intervention to evaluate the Lactobacillus plantarum 3547 probiotic effects over different inflammation and immune system markers, the experimental group took the experimental supplement (Lactobacillus plantarum 3547) during one period of parallel study (12 weeks), the volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 (10x109 cfu/d) immediately after finishing their meal, the capsule contains: 77 mg probiotic Lp3547 and 390 mg maltodextrins. The control group took the control supplement (Maltodextrin) during one period of parallel study (12 weeks), volunteers consumed 1 daily capsule of maltodextrin without Lactobacillus plantarum 3547 (Placebo) immediately after finishing their meal. (The capsule contains 425 mg of maltodextrin)
- Conditions
- VOLUNTEERS
- Being tested
- Lactobacillus plantarum 3547, Maltodextrin
- Keywords
- Lactobacillus plantarum, Maltodextrin, Probiotics, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum 3547Other
During one period of parallel study (12 weeks) volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 immediately after finishing their meal.
MaltodextrinDietary supplement
During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum 3547 | Experimental | 1 capsule/daily during 12 weeks with Lactobacillus plantarum 3547 (10x109 cfu/d). The capsule contains 77 mg probiotic Lp3547 and 390 mg maltodextrin Receives: Other: Lactobacillus plantarum 3547 |
| Maltodextrin | Placebo comparator | 1 daily capsule of maltodextrin (425 mg) during 12 weeks Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline interleukin 6 (IL-6)
Measured: 0 and 12 weeks
Change from baseline interleukin 1β (IL1β)
Measured: 0 and 12 weeks
Change from baseline interleukin 10 (IL10)
Measured: 0 and 12 weeks
Change from baseline cytokine Tumor necrosis factor (TNFα)
Measured: 0 and 12 weeks
Change from baseline Mcp1 (Monocyte Chemoattractant Protein-1)
Measured: 0 and 12 weeks
Transforming growth factor beta 1 (TGF-β1)
Measured: 0 and 12 weeks
Change from baseline Interferon gamma (INF-γ)
Measured: 0 and 12 weeks
Secondary outcomes (5)
Change from baseline cluster of differentiation 4 "CD4+T cells"
Measured: 0 and 12 weeks
Change from baseline T lymphocytes
Measured: 0 and 12 weeks
Change from baseline cluster of differentiation 8 "CD8+ T cells"
Measured: 0 and 12 weeks
Change from baseline natural killer cells
Measured: 0 and 12 weeks
Change from baseline B lymphocytes
Measured: 0 and 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 Dec 2015 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VOLUNTEERSStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Creaciones Aromáticas Industriales S.A.
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, MD, PhD, Principal investigator, La Paz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622867
- Sponsor's protocol ID
- Lactobacillus plantarum 3547
- Status last verified
- Dec 2015
- First submitted
- 18 Nov 2015
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention Clinical Trial to Evaluate the Lactobacillus Plantarum 3547 Probiotic Effects Over Different Inflammation and Immune System Markers in a Group of Healthy Middle-aged People
- ClinicalTrials.gov ID
- NCT02622867
- Acronym / sponsor ID
- Lactobacillus plantarum 3547
- Conditions
- VOLUNTEERS
- Keywords
- Lactobacillus plantarum, Maltodextrin, Probiotics, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Creaciones Aromáticas Industriales S.A.
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Dec 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 effects of the probiotic Lactobacillus plantarum 3547 over different inflammation and immune system markers on a healthy middle-aged group.
Detailed description
In this randomized double blind controlled trial, a group of healthy middle-aged people (45 to 65 years old) had a nutritional intervention to evaluate the Lactobacillus plantarum 3547 probiotic effects over different inflammation and immune system markers, the experimental group took the experimental supplement (Lactobacillus plantarum 3547) during one period of parallel study (12 weeks), the volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 (10x109 cfu/d) immediately after finishing their meal, the capsule contains: 77 mg probiotic Lp3547 and 390 mg maltodextrins. The control group took the control supplement (Maltodextrin) during one period of parallel study (12 weeks), volunteers consumed 1 daily capsule of maltodextrin without Lactobacillus plantarum 3547 (Placebo) immediately after finishing their meal. (The capsule contains 425 mg of maltodextrin)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum 3547 | Experimental | Other: Lactobacillus plantarum 35471 capsule/daily during 12 weeks with Lactobacillus plantarum 3547 (10x109 cfu/d). The capsule contains 77 mg probiotic Lp3547 and 390 mg maltodextrin |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin1 daily capsule of maltodextrin (425 mg) during 12 weeks |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women from 45 to 65 years old;
- Body Mass Index (BMI) ≥ 18,5 and < 40 kg/m2
- Signed informed consent.
- Adequate cultural level and understanding for the clinical trial.
- Free of infections at baseline
Key exclusion criteria (16 listed)
- Individuals with severe diseases (hepatic, kidney, cancer…);
- Individuals with diagnosed metabolic syndrome, diabetes and/or hyperthyroidism;
- Individuals with chronic intestinal pathologies (Gastritis, Colitis, Irritable Bowel Syndrome, Pseudomembranous Colitis, Crohn's disease…);
- Individuals with dementia, mental disease or low cognitive function;
- Individuals with autoimmune diseases and/or under treatment with corticosteroids and/or immunosuppressants;
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 |
|---|---|---|
| Lactobacillus plantarum 3547During one period of parallel study (12 weeks) volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 immediately after finishing their meal. | Other | Lactobacillus plantarum 3547 |
| MaltodextrinDuring one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal. | Dietary supplement | Maltodextrin |
Primary outcome
Change from baseline interleukin 6 (IL-6)
Time frame: 0 and 12 weeks
Change from baseline interleukin 1β (IL1β)
Time frame: 0 and 12 weeks
Change from baseline interleukin 10 (IL10)
Time frame: 0 and 12 weeks
Change from baseline cytokine Tumor necrosis factor (TNFα)
Time frame: 0 and 12 weeks
Change from baseline Mcp1 (Monocyte Chemoattractant Protein-1)
Time frame: 0 and 12 weeks
Transforming growth factor beta 1 (TGF-β1)
Time frame: 0 and 12 weeks
Change from baseline Interferon gamma (INF-γ)
Time frame: 0 and 12 weeks
5 secondary outcomes
Change from baseline cluster of differentiation 4 "CD4+T cells"
Time frame: 0 and 12 weeks
Change from baseline T lymphocytes
Time frame: 0 and 12 weeks
Change from baseline cluster of differentiation 8 "CD8+ T cells"
Time frame: 0 and 12 weeks
Change from baseline natural killer cells
Time frame: 0 and 12 weeks
Change from baseline B lymphocytes
Time frame: 0 and 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 7 Dec 2015.
- La Paz University Hospital Research InstituteLink provided by the sponsor.
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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.
Carmen Gómez Candela, MD, PhD principal investigator
La Paz University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactobacillus plantarum 3547 and Maltodextrin in people with VOLUNTEERS, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 16 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 7 Dec 2015. 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 Spain. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline interleukin 6 (IL-6) (time frame: 0 and 12 weeks). The study lists 7 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 7 Dec 2015.