Immune System Stimulation by Probiotic Food Supplementation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-08

Study Completion Date

2016-05-02

Brief Summary

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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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Detailed Description

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Conditions

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Flu Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Weiquan Yogurt with probiotics

Intervention Type DIETARY_SUPPLEMENT

150 ml daily consumption for a total of 12 weeks

Weiquan Yogurt without probiotics

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

Group Type PLACEBO_COMPARATOR

Weiquan Yogurt without probiotics

Intervention Type DIETARY_SUPPLEMENT

150 ml daily consumption for a total of 12 weeks

Interventions

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Weiquan Yogurt with probiotics

150 ml daily consumption for a total of 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Weiquan Yogurt without probiotics

150 ml daily consumption for a total of 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes