Title

Fermented Milk Drink on Human Intestinal Microflora
Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Study Participants

    24
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.
Study Started
Jan 31
2009
Primary Completion
Mar 31
2009
Study Completion
Mar 31
2009
Results Posted
Aug 19
2009
Estimate
Last Update
Sep 02
2009
Estimate

Dietary Supplement Yakult®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 Supplement Lactobacillus casei strain Shirota

Lactobacillus casei strain Shirota

1 Experimental

Fermented milk with Lactobacillus casei strain Shirota 100ml per day

2 Placebo Comparator

Unfermented milk without Lactobacillus casei strain Shirota 100ml per day

Criteria

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

Summary

Fermented Milk (Study Group)

Unfermented Milk (Placebo Group)

All Events

Event Type Organ System Event Term

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.

Fermented Milk (Study Group)

Week 0

7.88
log10 CFU/g (Log Mean)
Standard Deviation: 0.41

Week 1

8.13
log10 CFU/g (Log Mean)
Standard Deviation: 0.49

Week 2

9.03
log10 CFU/g (Log Mean)
Standard Deviation: 0.76

Week 3

8.87
log10 CFU/g (Log Mean)
Standard Deviation: 0.88

Week 4

9.43
log10 CFU/g (Log Mean)
Standard Deviation: 0.29

Week 5

9.14
log10 CFU/g (Log Mean)
Standard Deviation: 0.45

Week 6

8.51
log10 CFU/g (Log Mean)
Standard Deviation: 0.41

Unfermented Milk (Placebo Group)

Week 0

7.6
log10 CFU/g (Log Mean)
Standard Deviation: 0.63

Week 1

8.1
log10 CFU/g (Log Mean)
Standard Deviation: 0.78

Week 2

8.35
log10 CFU/g (Log Mean)
Standard Deviation: 0.59

Week 3

8.11
log10 CFU/g (Log Mean)
Standard Deviation: 0.82

Week 4

8.4
log10 CFU/g (Log Mean)
Standard Deviation: 0.52

Week 5

8.27
log10 CFU/g (Log Mean)
Standard Deviation: 0.44

Week 6

8.05
log10 CFU/g (Log Mean)
Standard Deviation: 0.63

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.

Fermented Milk (Study Group)

Week 0

7.13
log10 CFU/g (Log Mean)
Standard Deviation: 0.66

Week 1

7.61
log10 CFU/g (Log Mean)
Standard Deviation: 0.61

Week 2

8.04
log10 CFU/g (Log Mean)
Standard Deviation: 0.39

Week 3

7.53
log10 CFU/g (Log Mean)
Standard Deviation: 0.69

Week 4

7.29
log10 CFU/g (Log Mean)
Standard Deviation: 0.52

Week 5

6.0
log10 CFU/g (Log Mean)
Standard Deviation: 0.72

Week 6

6.57
log10 CFU/g (Log Mean)
Standard Deviation: 0.37

Unfermented Milk (Placebo Group)

Week 0

7.24
log10 CFU/g (Log Mean)
Standard Deviation: 0.59

Week 1

7.57
log10 CFU/g (Log Mean)
Standard Deviation: 0.57

Week 2

7.95
log10 CFU/g (Log Mean)
Standard Deviation: 0.31

Week 3

7.78
log10 CFU/g (Log Mean)
Standard Deviation: 0.37

Week 4

7.54
log10 CFU/g (Log Mean)
Standard Deviation: 0.43

Week 5

6.83
log10 CFU/g (Log Mean)
Standard Deviation: 0.74

Week 6

6.65
log10 CFU/g (Log Mean)
Standard Deviation: 0.63

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.

Outcome Measure Data Not Reported

Total

24
Participants

Age Continuous

31.21
years (Mean)
Standard Deviation: 5.17

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Fermented Milk (Study Group)

Unfermented Milk (Placebo Group)