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Completed

NCT Number: NCT00822328

Fermented Milk Drink on 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.

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Key information

Conditions

Signs and Symptoms, Digestive Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center

Taipei, 112, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yakult®300

Dietary 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.

Lactobacillus casei strain Shirota

Dietary Supplement

Lactobacillus casei strain Shirota

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cheng Hsin Rehabilitation Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 14, 2009
Registry last updated
Sep 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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