Fermented Milk Drink on Human Intestinal Microflora - Full Text View

Sponsor:	Cheng Hsin Rehabilitation Medical Center
Information provided by:	Cheng Hsin Rehabilitation Medical Center
ClinicalTrials.gov Identifier:	NCT00822328

Purpose

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.

Condition	Intervention	Phase
Signs and Symptoms, Digestive	Dietary Supplement: Yakult®300 Dietary Supplement: Lactobacillus casei strain Shirota	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

Drug Information available for: Lactobacillus

U.S. FDA Resources

Further study details as provided by Cheng Hsin Rehabilitation Medical Center:

Primary Outcome Measures:

Modification of the Composition of the Intestinal Microflora: Bifidobacterium [ Time Frame: week 0, 1, 2, 3, 4, 5, 6. ] [ Designated as safety issue: No ]
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens [ Time Frame: week 0, 1, 2, 3, 4, 5, 6. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota [ Time Frame: at week 0, 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	January 2009
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Fermented milk with Lactobacillus casei strain Shirota 100ml per day	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
Placebo Comparator: 2 Unfermented milk without Lactobacillus casei strain Shirota 100ml per day	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.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822328

Locations

Taiwan
Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center
Taipei, Taiwan, 112

Sponsors and Collaborators

Cheng Hsin Rehabilitation Medical Center

Investigators

Principal Investigator:

Yi-Hsien Lin, M.D.

Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center

More Information

No publications provided

Responsible Party:	Yi-Hsien Lin, Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center
ClinicalTrials.gov Identifier:	NCT00822328 History of Changes
Other Study ID Numbers:	CHGH-IRB(173)97B-13-1
Study First Received:	January 9, 2009
Results First Received:	March 23, 2009
Last Updated:	August 27, 2009
Health Authority:	Taiwan: Department of Health

Keywords provided by Cheng Hsin Rehabilitation Medical Center:

Probiotics
Lactobacillus
Intestine
Flora

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 24, 2012