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Completed

NCT Number: NCT03049579

Immune System Stimulation by Probiotic Food Supplementation

The purpose of this study is to investigate the effects of a probiotic supplementation on adult volunteers with having caught the common cold more than 4 times in the past year. This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a 12-week study period.

The incidence of flue and cold during the study period were compared between study groups.

Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.

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Key information

Conditions

Flu Symptom

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • male or female between 25 to 45 years old;
  • having caught the common cold or flu at least 4 to 6 times in the past calendar year;
  • signed the informed consent forms before entering the study;
  • fully understood the risks and potential benefits in participating this study.

Exclusion criteria

  • were diagnosed with the decreased immunity caused by any diagnosed chronic illness;
  • having any gastrointestinal illness with medical treatment at the time of being enrolled;
  • having any diagnosed respiratory illness with similar symptoms as the common cold and flu;
  • currently taking any pain killer drug;
  • having received any vaccine for the upper respiratory infection within 6 months before enrollment;
  • having received any purgative drug or digestion related drug within 2 weeks before enrollment;
  • having taken any dairy product containing prebiotics and probiotics within 10 days before enrollment;
  • currently taking any preventive drug for upper respiratory infection;
  • having received any drug which has impact with the immune system such as antibiotics within 3 months before enrollment;
  • alcoholic or addicted to any drug;
  • pregnant or breastfeeding mothers;
  • having participated another clinical trial within 3 months before enrollment.

Treatment and study plan

Weiquan Yogurt with probiotics

Dietary Supplement

150 ml daily consumption for a total of 12 weeks

Weiquan Yogurt without probiotics

Dietary Supplement

150 ml daily consumption for a total of 12 weeks

Primary outcomes

  1. Incidence of flue symptoms during the study

    Time frame: end of week 12

    Body temperature≥38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.

Secondary outcomes

  1. Incidence of cold symptoms during the study

    Time frame: end of week 12

    Body temperature<38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.

  2. Number of accumulated days of having cold symptoms during the study

    Time frame: End of week 12

    The total number of days of having one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite during the 12 week study period.

  3. Serum IFN-γ concentration

    Time frame: Baseline, end of week 12

    Interferon gamma (unit: pg/ml)

  4. Serum IL-4 concentration

    Time frame: Baseline, end of week 12

    Interleukin 4 (unit: ng/ml)

  5. Serum IL-10 concentration

    Time frame: Baseline, end of week 12

    Interleukin 10 (unit: pg/ml)

  6. Serum IgA concentration

    Time frame: Baseline, end of week 12

    Immunoglobulin A (unit: g/L)

  7. Serum IgG concentration

    Time frame: Baseline, end of week 12

    Immunoglobulin G (unit: g/L)

  8. Serum IgM concentration

    Time frame: Baseline, end of week 12

    Immunoglobulin M (unit: g/L)

  9. Fecal sIgA concentration

    Time frame: Baseline, end of week 12

    Secretory Immunoglobulin A (unit: ng/ml)

Sponsors and collaborators

Lead sponsor

Hangzhou Wei Chuan Foods Co., Ltd.

Industry

Registry information

Official study title

Immune System Stimulation by Probiotic Food Supplementation: a Double-blind, Randomized, Controlled, Parallel-designed, Prospective Trial

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2017
Registry last updated
Feb 10, 2017

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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