Fermented Milk Drink on Human Intestinal Microflora

August 27, 2009 updated by: Cheng Hsin Rehabilitation Medical Center

Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modification of the Composition of the Intestinal Microflora: Bifidobacterium
Time Frame: week 0, 1, 2, 3, 4, 5, 6.
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.
week 0, 1, 2, 3, 4, 5, 6.
Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens
Time Frame: week 0, 1, 2, 3, 4, 5, 6.

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.
week 0, 1, 2, 3, 4, 5, 6.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.

Bacterial colonies were cultured and counted.
at week 0, 1, 2, 3, 4, 5, 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cheng Hsin Rehabilitation Medical Center

Investigators

  • Principal Investigator: Yi-Hsien Lin, M.D., Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

September 2, 2009

Last Update Submitted That Met QC Criteria

August 27, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHGH-IRB(173)97B-13-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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