Flu SymptomNCT03049579
Immune System Stimulation by Probiotic Food Supplementation
A study testing Weiquan Yogurt with probiotics and Weiquan Yogurt without probiotics in people with Flu Symptom, run by Hangzhou Wei Chuan Foods Co., Ltd..
Trial summary
The purpose of this study is to investigate the effects of a probiotic supplementation on adult volunteers with having caught the common cold more than 4 times in the past year. This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Flu Symptom
- What is being tested?
- Weiquan Yogurt with probiotics and Weiquan Yogurt without probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2016to 2 May 2016
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female between 25 to 45 years old;
- having caught the common cold or flu at least 4 to 6 times in the past calendar year;
- signed the informed consent forms before entering the study;
- fully understood the risks and potential benefits in participating this study.
Who cannot join
- were diagnosed with the decreased immunity caused by any diagnosed chronic illness;
- having any gastrointestinal illness with medical treatment at the time of being enrolled;
- having any diagnosed respiratory illness with similar symptoms as the common cold and flu;
- currently taking any pain killer drug;
- having received any vaccine for the upper respiratory infection within 6 months before enrollment;
- having received any purgative drug or digestion related drug within 2 weeks before enrollment;
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- having taken any dairy product containing prebiotics and probiotics within 10 days before enrollment;
- currently taking any preventive drug for upper respiratory infection;
- having received any drug which has impact with the immune system such as antibiotics within 3 months before enrollment;
- alcoholic or addicted to any drug;
- pregnant or breastfeeding mothers;
- having participated another clinical trial within 3 months before enrollment.
About this study
Official title: Immune System Stimulation by Probiotic Food Supplementation: a Double-blind, Randomized, Controlled, Parallel-designed, Prospective Trial
The purpose of this study is to investigate the effects of a probiotic supplementation on adult volunteers with having caught the common cold more than 4 times in the past year. This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a 12-week study period.
The incidence of flue and cold during the study period were compared between study groups.
Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.
- Conditions
- Flu Symptom
- Being tested
- Weiquan Yogurt with probiotics, Weiquan Yogurt without probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weiquan Yogurt with probioticsDietary supplement
150 ml daily consumption for a total of 12 weeks
Weiquan Yogurt without probioticsDietary supplement
150 ml daily consumption for a total of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Weiquan Yogurt with probiotics | Experimental | Weiquan Yogurt with probiotics contained Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacillus casei 431® (108 CFU/ml) and Lactobacillus fermentum PCC® (106 CFU/ml) Receives: Dietary Supplement: Weiquan Yogurt with probiotics |
| Weiquan Yogurt without probiotics | Placebo comparator | Weiquan Yogurt devoid of probiotics, but otherwise similar to the experimental product. Receives: Dietary Supplement: Weiquan Yogurt without probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of flue symptoms during the study
Body temperature≥38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.
Measured: end of week 12
Secondary outcomes (9)
Incidence of cold symptoms during the study
Body temperature<38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.
Measured: end of week 12
Number of accumulated days of having cold symptoms during the study
The total number of days of having one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite during the 12 week study period.
Measured: End of week 12
Serum IFN-γ concentration
Interferon gamma (unit: pg/ml)
Measured: Baseline, end of week 12
Serum IL-4 concentration
Interleukin 4 (unit: ng/ml)
Measured: Baseline, end of week 12
Serum IL-10 concentration
Interleukin 10 (unit: pg/ml)
Measured: Baseline, end of week 12
Serum IgA concentration
Immunoglobulin A (unit: g/L)
Measured: Baseline, end of week 12
Serum IgG concentration
Immunoglobulin G (unit: g/L)
Measured: Baseline, end of week 12
Serum IgM concentration
Immunoglobulin M (unit: g/L)
Measured: Baseline, end of week 12
Fecal sIgA concentration
Secretory Immunoglobulin A (unit: ng/ml)
Measured: Baseline, end of week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start8 Jan 2016
- Primary completion10 Apr 2016
- Study completion2 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flu SymptomStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Wei Chuan Foods Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, MD, Study director, Sprim (Shanghai) Consulting Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049579
- Sponsor's protocol ID
- 15-SC-09-WQ-002
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 10 Feb 2017
- Results posted
- 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 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune System Stimulation by Probiotic Food Supplementation: a Double-blind, Randomized, Controlled, Parallel-designed, Prospective Trial
- ClinicalTrials.gov ID
- NCT03049579
- Acronym / sponsor ID
- 15-SC-09-WQ-002
- Conditions
- Flu Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hangzhou Wei Chuan Foods Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 10 Apr 2016 (actual)
- Study completion
- 2 May 2016 (actual)
- First posted
- 10 Feb 2017 (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 purpose of this study is to investigate the effects of a probiotic supplementation on adult volunteers with having caught the common cold more than 4 times in the past year. This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a 12-week study period.
The incidence of flue and cold during the study period were compared between study groups.
Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.
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 |
|---|---|---|
| Weiquan Yogurt with probiotics | Experimental | Dietary Supplement: Weiquan Yogurt with probioticsWeiquan Yogurt with probiotics contained Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacillus casei 431® (108 CFU/ml) and Lactobacillus fermentum PCC® (106 CFU/ml) |
| Weiquan Yogurt without probiotics | Placebo comparator | Dietary Supplement: Weiquan Yogurt without probioticsWeiquan Yogurt devoid of probiotics, but otherwise similar to the experimental product. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male or female between 25 to 45 years old;
- having caught the common cold or flu at least 4 to 6 times in the past calendar year;
- signed the informed consent forms before entering the study;
- fully understood the risks and potential benefits in participating this study.
Key exclusion criteria (12 listed)
- were diagnosed with the decreased immunity caused by any diagnosed chronic illness;
- having any gastrointestinal illness with medical treatment at the time of being enrolled;
- having any diagnosed respiratory illness with similar symptoms as the common cold and flu;
- currently taking any pain killer drug;
- having received any vaccine for the upper respiratory infection within 6 months before enrollment;
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 |
|---|---|---|
| Weiquan Yogurt with probiotics150 ml daily consumption for a total of 12 weeks | Dietary supplement | Weiquan Yogurt with probiotics |
| Weiquan Yogurt without probiotics150 ml daily consumption for a total of 12 weeks | Dietary supplement | Weiquan Yogurt without probiotics |
Primary outcome
Incidence of flue symptoms during the study
Time frame: end of week 12
Body temperature≥38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.
9 secondary outcomes
Incidence of cold symptoms during the study
Time frame: end of week 12
Number of accumulated days of having cold symptoms during the study
Time frame: End of week 12
Serum IFN-γ concentration
Time frame: Baseline, end of week 12
Serum IL-4 concentration
Time frame: Baseline, end of week 12
Serum IL-10 concentration
Time frame: Baseline, end of week 12
Serum IgA concentration
Time frame: Baseline, end of week 12
Serum IgG concentration
Time frame: Baseline, end of week 12
Serum IgM concentration
Time frame: Baseline, end of week 12
Fecal sIgA concentration
Time frame: Baseline, end of week 12
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 10 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Li Zhang, MD study director
Sprim (Shanghai) Consulting Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A study testing Weiquan Yogurt with probiotics and Weiquan Yogurt without probiotics in people with Flu Symptom, run by Hangzhou Wei Chuan Foods Co., Ltd..
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 4 inclusion and 12 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 10 Feb 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?
Incidence of flue symptoms during the study (time frame: end of week 12). 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 10 Feb 2017.