Fermented Milk Drink on Human Intestinal Microflora

• Sponsor: Cheng Hsin Rehabilitation Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00822328
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 1.9
• Patients Per Site Per Month: 12.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Signs and Symptoms, Digestive	Dietary Supplement: Yakult®300; Dietary Supplement: Lactobacillus casei strain Shirota	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Modification of the Composition of the Intestinal Microflora: Bifidobacterium [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.

2. Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens [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.

Secondary Outcome Measures

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]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00822328
• Other Study ID Numbers: CHGH-IRB(173)97B-13-1
• First Posted: Jan 14, 2009
• Last Update Posted: Sep 2, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Probiotics; Lactobacillus; Intestine; Flora
• Additional relevant MeSH terms: Signs and Symptoms, Digestive

Study Results

Participant Flow

Recruitment Details	24 healthy volunteers were recuited on Jan.11, 2009 at Cheng Hsin Rehabilitation Medical Center.

Arm/Group Title	Fermented Milk (Study Group)	Unfermented Milk (Placebo Group)
Arm/Group Description	Fermented milk with Lactobacillus casei strain Shirota 100ml per day	Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
Period Title: Overall Study
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Fermented Milk (Study Group)	Unfermented Milk (Placebo Group)	Total
Arm/Group Description	Fermented milk with Lactobacillus casei strain Shirota 100ml per day	Unfermented milk without Lactobacillus casei strain Shirota 100ml per day	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	12 100%	24 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.00 (3.54)	32.42 (6.33)	31.21 (5.17)
Sex: Female, Male (Count of Participants)
Female	8 66.7%	6 50%	14 58.3%
Male	4 33.3%	6 50%	10 41.7%
Region of Enrollment (participants) [Number]
Taiwan	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was per protocol analysis.

Arm/Group Title	Fermented Milk (Study Group)	Unfermented Milk (Placebo Group)
Arm/Group Description	Fermented milk with Lactobacillus casei strain Shirota 100ml per day	Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
Measure Participants	12	12
Week 0	7.88 (0.41)	7.60 (0.63)
Week 1	8.13 (0.49)	8.10 (0.78)
Week 2	9.03 (0.76)	8.35 (0.59)
Week 3	8.87 (0.88)	8.11 (0.82)
Week 4	9.43 (0.29)	8.40 (0.52)
Week 5	9.14 (0.45)	8.27 (0.44)
Week 6	8.51 (0.41)	8.05 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fermented Milk (Study Group), Unfermented Milk (Placebo Group)
	Comments	Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fermented Milk (Study Group)	Unfermented Milk (Placebo Group)
Arm/Group Description	Fermented milk with Lactobacillus casei strain Shirota 100ml per day	Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
Measure Participants	12	12
Week 0	7.13 (0.66)	7.24 (0.59)
Week 1	7.61 (0.61)	7.57 (0.57)
Week 2	8.04 (0.39)	7.95 (0.31)
Week 3	7.53 (0.69)	7.78 (0.37)
Week 4	7.29 (0.52)	7.54 (0.43)
Week 5	6.00 (0.72)	6.83 (0.74)
Week 6	6.57 (0.37)	6.65 (0.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fermented Milk (Study Group), Unfermented Milk (Placebo Group)
	Comments	Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Arm/Group Title	Fermented Milk (Study Group)		Unfermented Milk (Placebo Group)
Arm/Group Description	Fermented milk with Lactobacillus casei strain Shirota 100ml per day		Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
All Cause Mortality
	Fermented Milk (Study Group)		Unfermented Milk (Placebo Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fermented Milk (Study Group)		Unfermented Milk (Placebo Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/ (NaN)		0/ (NaN)
Other (Not Including Serious) Adverse Events
	Fermented Milk (Study Group)		Unfermented Milk (Placebo Group)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/ (NaN)		0/ (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.