InfluenzaNCT02909842
Effect of Drinking Fermented Milk on Immune Response
A study testing Drinking fermented milk and Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) in people with Influenza, run by Mahidol University.
Trial summary
This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Drinking fermented milk and Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Aug 2017
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 45 years old
- healthy and having normal vital signs
- no history of uncontrolled systemic or autoimmune diseases
- no signs or symptoms of respiratory infection
- normal blood chemistry including complete blood count (CBC), liver and kidney function, lipid profile and fasting blood sugar
- no history of influenza vaccine during the past 6 months
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- able to continuously take the intervention daily for 6 weeks
- able to refrain from other probiotic products such as drinking fermented milk or yoghurt since the beginning till the end of data collection
- accepted to receive influenza vaccine shot
- able to refrain from receiving other vaccine during the trial
- able to refrain from traveling to endemic area of influenza
- able to communicate in Thai and sign their written inform consent
Who cannot join
- under pregnancy or expected to be pregnant
- lactose or milk protein intolerances
- daily intake of probiotic product for one month prior to recruitment
- chronic alcoholism
- GI disturbance e.g. stomachache, frequent diarrhea or constipation
- history of GI surgery
- ongoing treatment with antibiotic or other immune affecting drugs e.g. glucocorticoids, chemotherapy, antibodies, ciclosporin, hormone and opioids
About this study
Official title: Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model
This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.
Read the detailed description
This study is conducted in healthy volunteer using product approved by Thai FDA. This blinded randomized controlled trial compare immune response against influenza H1N1, H3N2 and Phu-B between study group and control group. The study group receives influenza vaccine and drinking fermented milk containing Lactobacillus paracasei (IMULUS), while the control group receives influenza vaccine and placebo acidified milk. The trial lasts for 8 weeks and include four time points of data collection (0, 2, 6, 8 weeks). Subjects, outcome assessor and investigators are blinded throughout the study.
- Conditions
- Influenza
- Being tested
- Drinking fermented milk, placebo, Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)
- Keywords
- influenza, vaccine, probiotic, immune response
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinking fermented milkDietary supplement
Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
placeboDietary supplement
Acidified placebo milk with similar physical characteristics to the yoghurt drink
Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)Biological
Intramuscular injection of a single shot of influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS) Receives: Dietary Supplement: Drinking fermented milk; Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) |
| control group | Placebo comparator | Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of placebo, unlabelled acidified milk with similar physical and sensory appearance to the experimental one Receives: Dietary Supplement: placebo; Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response rate for H1N1, H3N2 and Phu-B virus
Number of subjects with increased HAI titer from baseline divided by total number of subjects
Measured: 4 weeks after vaccination
Secondary outcomes (4)
Antibody response rate for influenza A (H1N1+H3N2) virus
Number of subjects with increased Immunoglobulin G or M (IgG or IgM) antibody levels from baseline divided by total number of subjects
Measured: 4 weeks after vaccination
Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus
Changes in serum levels of IgM antibody against influenza A, detected by ELISA assay
Measured: 0, 2, 6 and 8 weeks after baseline
Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus
Changes in serum levels of IgG antibody against influenza A, detected by ELISA assay
Measured: 0, 2, 6 and 8 weeks after baseline
Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus
Changes in maximum dilution of serum, detected by Heme agglutination inhibition (HAI) assay , which can immunologically react against H1N1, H3N2 and Phu-B virus
Measured: 0, 2, 6 and 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start1 Jan 2016
- Primary completion1 Sep 2016
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dunyaporn Trachootham, Mahidol University
- Investigators
- Dunyaporn Trachootham, DDS, PhD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909842
- Sponsor's protocol ID
- MU-CIRB 2015/145.2509
- Status last verified
- Aug 2017
- First submitted
- 14 Sep 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only summary of data will be reported. No individual data will be released.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model
- ClinicalTrials.gov ID
- NCT02909842
- Acronym / sponsor ID
- MU-CIRB 2015/145.2509
- Conditions
- Influenza
- Keywords
- influenza, vaccine, probiotic, immune response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 21 Sep 2016 (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.
This blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.
Detailed description
This study is conducted in healthy volunteer using product approved by Thai FDA. This blinded randomized controlled trial compare immune response against influenza H1N1, H3N2 and Phu-B between study group and control group. The study group receives influenza vaccine and drinking fermented milk containing Lactobacillus paracasei (IMULUS), while the control group receives influenza vaccine and placebo acidified milk. The trial lasts for 8 weeks and include four time points of data collection (0, 2, 6, 8 weeks). Subjects, outcome assessor and investigators are blinded throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Dietary Supplement: Drinking fermented milk, Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of yoghurt drink, unlabelled drinking fermented milk containing probiotic, Lactobacillus paracasei (IMULUS) |
| control group | Placebo comparator | Dietary Supplement: placebo, Biological: Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) and 100 ml bottle of placebo, unlabelled acidified milk with similar physical and sensory appearance to the experimental one |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 18 45 years old
- healthy and having normal vital signs
- no history of uncontrolled systemic or autoimmune diseases
- no signs or symptoms of respiratory infection
- normal blood chemistry including complete blood count (CBC), liver and kidney function, lipid profile and fasting blood sugar
Key exclusion criteria (7 listed)
- under pregnancy or expected to be pregnant
- lactose or milk protein intolerances
- daily intake of probiotic product for one month prior to recruitment
- chronic alcoholism
- GI disturbance e.g. stomachache, frequent diarrhea or constipation
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 |
|---|---|---|
| Drinking fermented milkDrinking fermented milk containing Lactobacillus paracasei (IMULUS) | Dietary supplement | study group |
| placeboAcidified placebo milk with similar physical characteristics to the yoghurt drink | Dietary supplement | control group |
| Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)Intramuscular injection of a single shot of influenza vaccine | Biological | control group, study group |
Primary outcome
Immune response rate for H1N1, H3N2 and Phu-B virus
Time frame: 4 weeks after vaccination
Number of subjects with increased HAI titer from baseline divided by total number of subjects
4 secondary outcomes
Antibody response rate for influenza A (H1N1+H3N2) virus
Time frame: 4 weeks after vaccination
Changes from baseline immunoglobulin M (IgM) levels for influenza A (H1N1+H3N2) virus
Time frame: 0, 2, 6 and 8 weeks after baseline
Changes from baseline immunoglobulin G (IgG) levels for influenza A (H1N1+H3N2) virus
Time frame: 0, 2, 6 and 8 weeks after baseline
Changes from baseline HAI titer for H1N1, H3N2 and Phu-B virus
Time frame: 0, 2, 6 and 8 weeks after baseline
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 29 Aug 2017.
- Individual participant dataSharing planned: No. Only summary of data will be reported. No individual data will be released.
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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.
Dunyaporn Trachootham, DDS, PhD principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing Drinking fermented milk and Seasonal Influenza Vaccine (H1N1, H3N2, PhuB) in people with Influenza, run by Mahidol University.
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 12 inclusion and 7 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 29 Aug 2017. 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. 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?
Immune response rate for H1N1, H3N2 and Phu-B virus (time frame: 4 weeks after vaccination). 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 29 Aug 2017.