Clinical trial NCT03049579: Immune System Stimulation by Probiotic Food Supplementation
Official title: Immune System Stimulation by Probiotic Food Supplementation: a Double-blind, Randomized, Controlled, Parallel-designed, Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flu Symptom
Lead sponsor: Hangzhou Wei Chuan Foods Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-10
Enrollment: 136
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of flue symptoms during the study
timeFrame: end of week 12
Secondary outcomes:
measure: Incidence of cold symptoms during the study
timeFrame: end of week 12
measure: Number of accumulated days of having cold symptoms during the study
timeFrame: End of week 12
measure: Serum IFN-γ concentration
timeFrame: Baseline, end of week 12
measure: Serum IL-4 concentration
timeFrame: Baseline, end of week 12
measure: Serum IL-10 concentration
timeFrame: Baseline, end of week 12
measure: Serum IgA concentration
timeFrame: Baseline, end of week 12
measure: Serum IgG concentration
timeFrame: Baseline, end of week 12
measure: Serum IgM concentration
timeFrame: Baseline, end of week 12
measure: Fecal sIgA concentration
timeFrame: Baseline, end of week 12
Other outcomes:
Locations:
Study officials:
affiliation: Sprim (Shanghai) Consulting Co., Ltd.
name: Li Zhang, MD
role: STUDY_DIRECTOR
References: