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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014