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Immune System Stimulation by Probiotic Food Supplementation

NCT03049579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2017-02-10

No results posted yet for this study

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.

Conditions

  • Flu Symptom

Interventions

DIETARY_SUPPLEMENT

Weiquan Yogurt with probiotics

150 ml daily consumption for a total of 12 weeks

DIETARY_SUPPLEMENT

Weiquan Yogurt without probiotics

150 ml daily consumption for a total of 12 weeks

Sponsors & Collaborators

  • Hangzhou Wei Chuan Foods Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, MD · Sprim (Shanghai) Consulting Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-08
Primary Completion
2016-04-10
Completion
2016-05-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049579 on ClinicalTrials.gov