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Fermented Milk Drink on Human Intestinal Microflora

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ClinicalTrials.gov Identifier: NCT00822328
Recruitment Status : Completed
First Posted : January 14, 2009
Results First Posted : August 19, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Cheng Hsin Rehabilitation Medical Center

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Modification of the Composition of the Intestinal Microflora: Bifidobacterium [ Time Frame: week 0, 1, 2, 3, 4, 5, 6. ]
  2. Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens [ Time Frame: week 0, 1, 2, 3, 4, 5, 6. ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 14, 2009    Key Record Dates
Results First Posted: August 19, 2009
Last Update Posted: September 2, 2009
Last Verified: August 2009

Keywords provided by Cheng Hsin Rehabilitation Medical Center:
Probiotics
Lactobacillus
Intestine
Flora

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive