Fermented Milk Drink on Human Intestinal Microflora

Cheng Hsin Rehabilitation Medical Center

Status and phase: Completed; Phase 2

Conditions: Signs and Symptoms, Digestive

Treatments: Dietary Supplement: Lactobacillus casei strain Shirota; Dietary Supplement: Yakult®300

Study type: Interventional

Funder types: Other

Identifiers

NCT00822328

CHGH-IRB(173)97B-13-1

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Fermented milk with Lactobacillus casei strain Shirota 100ml per day

Treatment:

Dietary Supplement: Lactobacillus casei strain Shirota

Dietary Supplement: Yakult®300

2

Placebo Comparator group

Description:

Unfermented milk without Lactobacillus casei strain Shirota 100ml per day

Treatment:

Dietary Supplement: Yakult®300