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Fermented milk is a popular drink. Recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. Lactobacillus casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced immune responses in allergic rhinitis, altering fermentation patterns in the small bowel, prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk containing at least 3x10^10 live LcS cells per 100 ml bottle. This study aimed to evaluate the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the human intestinal microflora.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fermented milk with Lactobacillus casei strain Shirota 100ml per day |
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| 2 | Placebo Comparator | Unfermented milk without Lactobacillus casei strain Shirota 100ml per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yakult®300 | Dietary Supplement | Yakult®300 was given 100 ml once per day for four weeks. Fermented or unfermented milk per 100 ml bottle per day for four week. |
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| Measure | Description | Time Frame |
|---|---|---|
| Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted. | week 0, 1, 2, 3, 4, 5, 6. |
| Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Clostridium perfringens was cultured.Bacterial colonies were counted. | week 0, 1, 2, 3, 4, 5, 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota | Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bacterial colonies were cultured and counted. | at week 0, 1, 2, 3, 4, 5, 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Hsien Lin, M.D. | Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center | Taipei | 112 | Taiwan |
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24 healthy volunteers were recuited on Jan.11, 2009 at Cheng Hsin Rehabilitation Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fermented Milk (Study Group) | Fermented milk with Lactobacillus casei strain Shirota 100ml per day |
| FG001 | Unfermented Milk (Placebo Group) | Unfermented milk without Lactobacillus casei strain Shirota 100ml per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fermented Milk (Study Group) | Fermented milk with Lactobacillus casei strain Shirota 100ml per day |
| BG001 | Unfermented Milk (Placebo Group) | Unfermented milk without Lactobacillus casei strain Shirota 100ml per day |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted. | The number of participants for analysis was per protocol analysis. | Posted | Log Mean | Standard Deviation | log10 CFU/g | week 0, 1, 2, 3, 4, 5, 6. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fermented Milk (Study Group) | Fermented milk with Lactobacillus casei strain Shirota 100ml per day |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Yi-Hsien Lin | Cheng Hsin Rehabilitation Medical Center | +886-2-28264400 | 5750 | d49311001@ym.edu.tw |
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| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Lactobacillus casei strain Shirota | Dietary Supplement | Lactobacillus casei strain Shirota |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota | Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bacterial colonies were cultured and counted. | Not Posted | Mar 2009 | Log Mean | Standard Deviation | log10 CFU/g | at week 0, 1, 2, 3, 4, 5, 6 |
| Primary | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Clostridium perfringens was cultured.Bacterial colonies were counted. | Posted | Log Mean | Standard Deviation | log10 CFU/g | week 0, 1, 2, 3, 4, 5, 6. |
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| EG001 | Unfermented Milk (Placebo Group) | Unfermented milk without Lactobacillus casei strain Shirota 100ml per day | 0 | 0 |
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