Immune System Stimulation by Probiotic Food Supplementation

NCT03049579 | Completed

• 1 other identifier: 15-SC-09-WQ-002
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Flu Symptom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of cold symptoms during the study

  end of week 12

• Number of accumulated days of having cold symptoms during the study

  End of week 12

• Serum IFN-γ concentration

  Baseline, end of week 12

• Serum IL-4 concentration

  Baseline, end of week 12

• Serum IL-10 concentration

  Baseline, end of week 12

Study Arms (2)

Weiquan Yogurt with probiotics

EXPERIMENTAL

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)

Dietary Supplement: Weiquan Yogurt with probiotics

Weiquan Yogurt without probiotics

PLACEBO COMPARATOR

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

Dietary Supplement: Weiquan Yogurt without probiotics

Interventions

Weiquan Yogurt with probiotics DIETARY_SUPPLEMENT

150 ml daily consumption for a total of 12 weeks

Weiquan Yogurt with probiotics

Weiquan Yogurt without probiotics DIETARY_SUPPLEMENT

150 ml daily consumption for a total of 12 weeks

Weiquan Yogurt without probiotics

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Wei Chuan Foods Co., Ltd.: lead

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Li Zhang, MD

  Sprim (Shanghai) Consulting Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: January 8, 2016
• Primary Completion: April 10, 2016
• Study Completion: May 2, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share