Fermented Milk Drink on Human Intestinal Microflora

Phase 2

Completed

• Conditions: Signs and Symptoms, Digestive
• Interventions: Dietary Supplement: Yakult®300; Dietary Supplement: Lactobacillus casei strain Shirota

• Registration Number: NCT00822328
• Lead Sponsor: Cheng Hsin Rehabilitation Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2009-03-23
• Results First Submitted QC: 2009-07-08
• Status Verified: 2009-08
• Results First Posted: 2009-08-19
• Last Update Submitted: 2009-08-27
• Last Update Posted: 2009-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Yakult®300	Fermented milk with Lactobacillus casei strain Shirota 100ml per day
1	Lactobacillus casei strain Shirota	Fermented milk with Lactobacillus casei strain Shirota 100ml per day
2	Yakult®300	Unfermented milk without Lactobacillus casei strain Shirota 100ml per day

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center; 🇨🇳 Taipei, Taiwan