Immune System Stimulation by Probiotic Food Supplementation

Hangzhou Wei Chuan Foods

Status: Completed

Conditions: Flu Symptom

Treatments: Dietary Supplement: Weiquan Yogurt without probiotics; Dietary Supplement: Weiquan Yogurt with probiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT03049579

15-SC-09-WQ-002

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 2 patient groups, including a placebo group

Weiquan Yogurt with probiotics

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Weiquan Yogurt with probiotics

Weiquan Yogurt without probiotics

Placebo Comparator group

Description:

Weiquan Yogurt devoid of probiotics, but otherwise similar to the experimental product.

Treatment:

Dietary Supplement: Weiquan Yogurt without probiotics