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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Weiquan Yogurt without probiotics | Placebo Comparator | Weiquan Yogurt devoid of probiotics, but otherwise similar to the experimental product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weiquan Yogurt with probiotics | Dietary Supplement | 150 ml daily consumption for a total of 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | end of week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | end of week 12 |
| Number of accumulated days of having cold symptoms during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, MD | Sprim (Shanghai) Consulting Co., Ltd. | Study Director |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Weiquan Yogurt without probiotics | Dietary Supplement | 150 ml daily consumption for a total of 12 weeks |
|
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. |
| End of week 12 |
| Serum IFN-γ concentration | Interferon gamma (unit: pg/ml) | Baseline, end of week 12 |
| Serum IL-4 concentration | Interleukin 4 (unit: ng/ml) | Baseline, end of week 12 |
| Serum IL-10 concentration | Interleukin 10 (unit: pg/ml) | Baseline, end of week 12 |
| Serum IgA concentration | Immunoglobulin A (unit: g/L) | Baseline, end of week 12 |
| Serum IgG concentration | Immunoglobulin G (unit: g/L) | Baseline, end of week 12 |
| Serum IgM concentration | Immunoglobulin M (unit: g/L) | Baseline, end of week 12 |
| Fecal sIgA concentration | Secretory Immunoglobulin A (unit: ng/ml) | Baseline, end of week 12 |
| D019602 |
| Food and Beverages |