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Fermented Milk Drink on Human Intestinal Microflora

Primary Purpose

Signs and Symptoms, Digestive

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Yakult®300
Lactobacillus casei strain Shirota
Sponsored by
Cheng Hsin Rehabilitation Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Signs and Symptoms, Digestive focused on measuring Probiotics, Lactobacillus, Intestine, Flora

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Fermented milk with Lactobacillus casei strain Shirota 100ml per day

Unfermented milk without Lactobacillus casei strain Shirota 100ml per day

Outcomes

Primary Outcome Measures

Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Clostridium perfringens was cultured.Bacterial colonies were counted.

Secondary Outcome Measures

Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bacterial colonies were cultured and counted.

Full Information

First Posted
January 9, 2009
Last Updated
August 27, 2009
Sponsor
Cheng Hsin Rehabilitation Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00822328
Brief Title
Fermented Milk Drink on Human Intestinal Microflora
Official Title
Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cheng Hsin Rehabilitation Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Signs and Symptoms, Digestive
Keywords
Probiotics, Lactobacillus, Intestine, Flora

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fermented milk with Lactobacillus casei strain Shirota 100ml per day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Yakult®300
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus casei strain Shirota
Intervention Description
Lactobacillus casei strain Shirota
Primary Outcome Measure Information:
Title
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Description
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.
Time Frame
week 0, 1, 2, 3, 4, 5, 6.
Title
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Description
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Clostridium perfringens was cultured.Bacterial colonies were counted.
Time Frame
week 0, 1, 2, 3, 4, 5, 6.
Secondary Outcome Measure Information:
Title
Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota
Description
Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bacterial colonies were cultured and counted.
Time Frame
at week 0, 1, 2, 3, 4, 5, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Hsien Lin, M.D.
Organizational Affiliation
Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

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Fermented Milk Drink on Human Intestinal Microflora

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