Immune ModulationNCT06747143
Short-term Immunomodulatory Effects of Lactobacillus Casei DN-114001: Impacts on Gut Microbiota Composition and Systemic Immune Biomarkers in Healthy Adults
A study testing Lactobacillus casei DN-114001 in people with Immune Modulation, run by University of Valladolid.
Trial summary
The study included 21 adult participants, aged 19-46 years (19 female participants and 2 male participants). The selection criteria included the following parameters: Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), between 18.5 and 29.99; Waist-to-Hip Ratio with thresholds set at >0.90… Read more about this study
- Who is it for?
- Ages 19 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Modulation
- What is being tested?
- Lactobacillus casei DN-114001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2013to Sep 2013
- 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 19 to 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 18.5 and 29.99;
- Waist-to-Hip Ratio with thresholds set at >0.90 for males and >0.85 for females for individuals with normal weight (eutrophic)
- Percentage of body fat: Considered within normal range if <30% for individuals with normal weight.
Who cannot join
None listed.
About this study
Official title: "Study of Immunological Biomarkers in Response to Probiotic Intake"
The study included 21 adult participants, aged 19-46 years (19 female participants and 2 male participants). The selection criteria included the following parameters: Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), between 18.5 and 29.99; Waist-to-Hip Ratio with thresholds set at >0.90 for males and >0.85 for females for individuals with normal weight (eutrophic); percentage of body fat: Considered within normal range if <30% for individuals with normal weight. Standard biochemical and anthropometric measurements were carried out to all the subjects.
- Conditions
- Immune Modulation
- Being tested
- Lactobacillus casei DN-114001
- Keywords
- lactobacillus casei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei DN-114001Dietary supplement
Also called Actimel
Probiotic
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Healthy subjects Receives: Dietary Supplement: Lactobacillus casei DN-114001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal flora cultures (Count of colonies/mL)
Relative amount of colonies (CFU) of Escherichia coli, Clostridium species and Lactobacillus
Measured: From enrollment to the end of treatment at 45 days weeks, every 15 days
Serum immunoglobulins
Serum concentration of G, A, M, and G subclasses, as well as the complement C3 and C4 factors,
Measured: From enrollment to the end of treatment at 45 days weeks, every 15 days
Lymphocyte Subpopulations
Concentration of T Lymphocytes: CD3, CD4, CD8, CD45 RA, and CD45 RO (distinguishing between helper T cells, cytotoxic T cells, and naïve or memory subsets within each group). ii) B Lymphocytes: CD19; iii) NK Cells: CD16 and CD56.
Measured: From enrollment to the end of treatment at 45 days weeks, every 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Feb 2013
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ModulationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential intervention
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, Alfredo Corell, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747143
- Sponsor's protocol ID
- PROBIOINMUNE2003
- Status last verified
- Jan 2025
- First submitted
- 18 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not needed
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Study of Immunological Biomarkers in Response to Probiotic Intake"
- ClinicalTrials.gov ID
- NCT06747143
- Acronym / sponsor ID
- PROBIOINMUNE2003
- Conditions
- Immune Modulation
- Keywords
- lactobacillus casei
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- 1 Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Dec 2024 (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.
The study included 21 adult participants, aged 19-46 years (19 female participants and 2 male participants). The selection criteria included the following parameters: Body Mass Index (BMI), calculated as weight (kg) divided by height squared (m²), between 18.5 and 29.99; Waist-to-Hip Ratio with thresholds set at >0.90 for males and >0.85 for females for individuals with normal weight (eutrophic); percentage of body fat: Considered within normal range if <30% for individuals with normal weight. Standard biochemical and anthropometric measurements were carried out to all the subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Lactobacillus casei DN-114001Healthy subjects |
Who may qualify
- Ages
- 19 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) between 18.5 and 29.99;
- Waist-to-Hip Ratio with thresholds set at >0.90 for males and >0.85 for females for individuals with normal weight (eutrophic)
- Percentage of body fat: Considered within normal range if <30% for individuals with normal weight.
Key exclusion criteria (0 listed)
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 casei DN-114001Also: ActimelProbiotic | Dietary supplement | Intervention group |
Primary outcome
Fecal flora cultures (Count of colonies/mL)
Time frame: From enrollment to the end of treatment at 45 days weeks, every 15 days
Relative amount of colonies (CFU) of Escherichia coli, Clostridium species and Lactobacillus
Serum immunoglobulins
Time frame: From enrollment to the end of treatment at 45 days weeks, every 15 days
Serum concentration of G, A, M, and G subclasses, as well as the complement C3 and C4 factors,
Lymphocyte Subpopulations
Time frame: From enrollment to the end of treatment at 45 days weeks, every 15 days
Concentration of T Lymphocytes: CD3, CD4, CD8, CD45 RA, and CD45 RO (distinguishing between helper T cells, cytotoxic T cells, and naïve or memory subsets within each group). ii) B Lymphocytes: CD19; iii) NK Cells: CD16 and CD56.
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 6 Jan 2025.
- Individual participant dataSharing planned: No. Not needed
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei DN-114001 in people with Immune Modulation, run by University of Valladolid.
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 0 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 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Fecal flora cultures (Count of colonies/mL) (time frame: From enrollment to the end of treatment at 45 days weeks, every 15 days). 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 6 Jan 2025.