Immune System Stimulation by Probiotic Food Supplementation

Not Applicable

Completed

• Conditions: Flu Symptom
• Interventions: Dietary Supplement: Weiquan Yogurt with probiotics; Dietary Supplement: Weiquan Yogurt without probiotics

• Registration Number: NCT03049579
• Lead Sponsor: Hangzhou Wei Chuan Foods Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-08
• Primary Completion: 2016-04-10
• Study Completion: 2016-05-02
• Status Verified: 2017-02
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-09
• Last Update Submitted: 2017-02-09
• Study First Posted: 2017-02-10
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weiquan Yogurt with probiotics	Weiquan Yogurt with probiotics	Weiquan Yogurt with probiotics contained Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacillus casei 431® (108 CFU/ml) and Lactobacillus fermentum PCC® (106 CFU/ml)
Weiquan Yogurt without probiotics	Weiquan Yogurt without probiotics	Weiquan Yogurt devoid of probiotics, but otherwise similar to the experimental product.

Primary Outcome Measures

Name	Time	Method
Incidence of flue symptoms during the study	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 Outcome Measures

Name	Time	Method
Serum IgA concentration	Baseline, end of week 12	Immunoglobulin A (unit: g/L)
Serum IL-4 concentration	Baseline, end of week 12	Interleukin 4 (unit: ng/ml)
Serum IgG concentration	Baseline, end of week 12	Immunoglobulin G (unit: g/L)
Incidence of cold symptoms during the study	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.
Number of accumulated days of having cold symptoms during the study	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.
Serum IFN-γ concentration	Baseline, end of week 12	Interferon gamma (unit: pg/ml)
Fecal sIgA concentration	Baseline, end of week 12	Secretory Immunoglobulin A (unit: ng/ml)
Serum IL-10 concentration	Baseline, end of week 12	Interleukin 10 (unit: pg/ml)
Serum IgM concentration	Baseline, end of week 12	Immunoglobulin M (unit: g/L)