Signs and Symptoms, Digestive
Conditions
Keywords
Probiotics, Lactobacillus, Intestine, Flora
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTYakult®300
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.
DIETARY_SUPPLEMENTLactobacillus casei strain Shirota
Lactobacillus casei strain Shirota
Sponsors
Cheng Hsin Rehabilitation Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult volunteers and willing to give voluntary written informed consent
Exclusion criteria
* Major systemic disease * Pregnancy, parturient and feeding woman, or expect to be pregnant * Abnormal liver function * Abnormal renal function * Abnormal gastrointestinal function * Take medication for gastrointestinal function * Stroke, myocardial infarction, * Poor compliance for study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modification of the Composition of the Intestinal Microflora: Bifidobacterium | week 0, 1, 2, 3, 4, 5, 6. | 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. |
| Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | week 0, 1, 2, 3, 4, 5, 6. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota | at week 0, 1, 2, 3, 4, 5, 6 | Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bacterial colonies were cultured and counted. |
Countries
Taiwan
Participant flow
Recruitment details
24 healthy volunteers were recuited on Jan.11, 2009 at Cheng Hsin Rehabilitation Medical Center.
Participants by arm
| Arm | Count |
|---|---|
| Fermented Milk (Study Group) Fermented milk with Lactobacillus casei strain Shirota 100ml per day | 12 |
| Unfermented Milk (Placebo Group) Unfermented milk without Lactobacillus casei strain Shirota 100ml per day | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Unfermented Milk (Placebo Group) | Fermented Milk (Study Group) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 12 Participants | 24 Participants |
| Age Continuous | 32.42 years STANDARD_DEVIATION 6.33 | 30.00 years STANDARD_DEVIATION 3.54 | 31.21 years STANDARD_DEVIATION 5.17 |
| Region of Enrollment Taiwan | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / — | 0 / — |
| serious Total, serious adverse events | 0 / — | 0 / — |
Outcome results
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.
Time frame: week 0, 1, 2, 3, 4, 5, 6.
Population: The number of participants for analysis was per protocol analysis.
| Arm | Measure | Group | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|---|
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 2 | 9.03 log10 CFU/g | Standard Deviation 0.76 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 4 | 9.43 log10 CFU/g | Standard Deviation 0.29 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 1 | 8.13 log10 CFU/g | Standard Deviation 0.49 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 5 | 9.14 log10 CFU/g | Standard Deviation 0.45 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 3 | 8.87 log10 CFU/g | Standard Deviation 0.88 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 6 | 8.51 log10 CFU/g | Standard Deviation 0.41 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 0 | 7.88 log10 CFU/g | Standard Deviation 0.41 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 6 | 8.05 log10 CFU/g | Standard Deviation 0.63 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 0 | 7.60 log10 CFU/g | Standard Deviation 0.63 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 1 | 8.10 log10 CFU/g | Standard Deviation 0.78 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 2 | 8.35 log10 CFU/g | Standard Deviation 0.59 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 3 | 8.11 log10 CFU/g | Standard Deviation 0.82 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 4 | 8.40 log10 CFU/g | Standard Deviation 0.52 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Bifidobacterium | Week 5 | 8.27 log10 CFU/g | Standard Deviation 0.44 |
Comparison: Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).p-value: <0.05ANOVA
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.
Time frame: week 0, 1, 2, 3, 4, 5, 6.
| Arm | Measure | Group | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|---|
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 0 | 7.13 log10 CFU/g | Standard Deviation 0.66 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 4 | 7.29 log10 CFU/g | Standard Deviation 0.52 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 2 | 8.04 log10 CFU/g | Standard Deviation 0.39 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 5 | 6.00 log10 CFU/g | Standard Deviation 0.72 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 1 | 7.61 log10 CFU/g | Standard Deviation 0.61 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 6 | 6.57 log10 CFU/g | Standard Deviation 0.37 |
| Fermented Milk (Study Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 3 | 7.53 log10 CFU/g | Standard Deviation 0.69 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 6 | 6.65 log10 CFU/g | Standard Deviation 0.63 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 0 | 7.24 log10 CFU/g | Standard Deviation 0.59 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 1 | 7.57 log10 CFU/g | Standard Deviation 0.57 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 2 | 7.95 log10 CFU/g | Standard Deviation 0.31 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 3 | 7.78 log10 CFU/g | Standard Deviation 0.37 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 4 | 7.54 log10 CFU/g | Standard Deviation 0.43 |
| Unfermented Milk (Placebo Group) | Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens | Week 5 | 6.83 log10 CFU/g | Standard Deviation 0.74 |
Comparison: Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).p-value: <0.05ANOVA
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.
Time frame: at week 0, 1, 2, 3, 4, 5, 6