Fermented Milk Drink on Human Intestinal Microflora

Signs and Symptoms, Digestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822328
• Other study ID #: CHGH-IRB(173)97B-13-1
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2009
• Last updated: August 27, 2009
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: August 2009
• Source: Cheng Hsin Rehabilitation Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Signs and Symptoms
• Signs and Symptoms, Digestive

Intervention

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.
• Lactobacillus casei strain Shirota
Lactobacillus casei strain Shirota

Locations

Country	Name	City	State
Taiwan	Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Cheng Hsin Rehabilitation Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification of the Composition of the Intestinal Microflora: Bifidobacterium		week 0, 1, 2, 3, 4, 5, 6.	No
Primary	Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens		week 0, 1, 2, 3, 4, 5, 6.	No
Secondary	Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota		at week 0, 1, 2, 3, 4, 5, 6	No