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Fermented Milk Drink on Human Intestinal Microflora

This study has been completed.
Sponsor:
Information provided by:
Cheng Hsin Rehabilitation Medical Center
ClinicalTrials.gov Identifier:
NCT00822328
First received: January 9, 2009
Last updated: August 27, 2009
Last verified: August 2009
History of Changes
  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
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 16, 2013