NCT00822328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 19, 2009

Completed
Last Updated

September 2, 2009

Status Verified

August 1, 2009

Enrollment Period

2 months

First QC Date

January 9, 2009

Results QC Date

March 23, 2009

Last Update Submit

August 27, 2009

Conditions

Signs and Symptoms, Digestive

Keywords

ProbioticsLactobacillusIntestineFlora

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (1)

  • Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota

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

Study Arms (2)

1

EXPERIMENTAL

Fermented milk with Lactobacillus casei strain Shirota 100ml per day

Dietary Supplement: Yakult®300Dietary Supplement: Lactobacillus casei strain Shirota

2

PLACEBO COMPARATOR

Unfermented milk without Lactobacillus casei strain Shirota 100ml per day

Dietary Supplement: Yakult®300

Interventions

Yakult®300DIETARY_SUPPLEMENT

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.

12
Lactobacillus casei strain ShirotaDIETARY_SUPPLEMENT

Lactobacillus casei strain Shirota

1

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult volunteers and willing to give voluntary written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Signs and Symptoms, Digestive

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr.Yi-Hsien Lin
Organization
Cheng Hsin Rehabilitation Medical Center
d49311001@ym.edu.tw
+886-2-28264400

Study Officials

  • Yi-Hsien Lin, M.D.

    Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 14, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

September 2, 2009

Results First Posted

August 19, 2009

Record last verified: 2009-08

Locations

TW(1)