Immune System Stimulation by Probiotic Food Supplementation

Flu Symptom Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049579
• Other study ID #: 15-SC-09-WQ-002
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 9, 2017
• Start date: January 8, 2016
• Est. completion date: May 2, 2016

Study information

• Verified date: February 2017
• Source: Hangzhou Wei Chuan Foods Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2, 2016
• Est. primary completion date: April 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flu Symptom

Intervention

Dietary Supplement:
• Weiquan Yogurt with probiotics
150 ml daily consumption for a total of 12 weeks
• Weiquan Yogurt without probiotics
150 ml daily consumption for a total of 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Wei Chuan Foods Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of flue symptoms during the study	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.	end of week 12
Secondary	Incidence of cold symptoms during the study	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.	end of week 12
Secondary	Number of accumulated days of having cold symptoms during the study	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.	End of week 12
Secondary	Serum IFN-? concentration	Interferon gamma (unit: pg/ml)	Baseline, end of week 12
Secondary	Serum IL-4 concentration	Interleukin 4 (unit: ng/ml)	Baseline, end of week 12
Secondary	Serum IL-10 concentration	Interleukin 10 (unit: pg/ml)	Baseline, end of week 12
Secondary	Serum IgA concentration	Immunoglobulin A (unit: g/L)	Baseline, end of week 12
Secondary	Serum IgG concentration	Immunoglobulin G (unit: g/L)	Baseline, end of week 12
Secondary	Serum IgM concentration	Immunoglobulin M (unit: g/L)	Baseline, end of week 12
Secondary	Fecal sIgA concentration	Secretory Immunoglobulin A (unit: ng/ml)	Baseline, end of week 12