## Protocol Section
### Identification Module
**NCT ID:** NCT03049579

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 15-SC-09-WQ-002
#### Organization
**Class:** INDUSTRY
**Full Name:** Hangzhou Wei Chuan Foods Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2016-05-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-10

**Type:** ACTUAL

**Last Update Submit Date:** 2017-02-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-04-10

**Type:** ACTUAL

#### Start Date
**Date:** 2016-01-08

**Type:** ACTUAL

**Status Verified Date:** 2017-02

#### Study First Post Date
**Date:** 2017-02-10
**Type:** ACTUAL
**Study First Submit Date:** 2017-02-08
**Study First Submit QC Date:** 2017-02-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hangzhou Wei Chuan Foods Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Flu Symptom

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 136

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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)

**Intervention Names:**

- Dietary Supplement: Weiquan Yogurt with probiotics

**Label:** Weiquan Yogurt with probiotics

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Dietary Supplement: Weiquan Yogurt without probiotics

**Label:** Weiquan Yogurt without probiotics

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Weiquan Yogurt with probiotics

**Description:** 150 ml daily consumption for a total of 12 weeks

**Name:** Weiquan Yogurt with probiotics

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Weiquan Yogurt without probiotics

**Description:** 150 ml daily consumption for a total of 12 weeks

**Name:** Weiquan Yogurt without probiotics

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Incidence of flue symptoms during the study

**Time Frame:** end of week 12

#### Secondary Outcomes

**Description:** 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.

**Measure:** Incidence of cold symptoms during the study

**Time Frame:** end of week 12

**Description:** 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.

**Measure:** Number of accumulated days of having cold symptoms during the study

**Time Frame:** End of week 12

**Description:** Interferon gamma (unit: pg/ml)

**Measure:** Serum IFN-γ concentration

**Time Frame:** Baseline, end of week 12

**Description:** Interleukin 4 (unit: ng/ml)

**Measure:** Serum IL-4 concentration

**Time Frame:** Baseline, end of week 12

**Description:** Interleukin 10 (unit: pg/ml)

**Measure:** Serum IL-10 concentration

**Time Frame:** Baseline, end of week 12

**Description:** Immunoglobulin A (unit: g/L)

**Measure:** Serum IgA concentration

**Time Frame:** Baseline, end of week 12

**Description:** Immunoglobulin G (unit: g/L)

**Measure:** Serum IgG concentration

**Time Frame:** Baseline, end of week 12

**Description:** Immunoglobulin M (unit: g/L)

**Measure:** Serum IgM concentration

**Time Frame:** Baseline, end of week 12

**Description:** Secretory Immunoglobulin A (unit: ng/ml)

**Measure:** Fecal sIgA concentration

**Time Frame:** Baseline, end of week 12

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 25 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Sprim (Shanghai) Consulting Co., Ltd.

**Name:** Li Zhang, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10295

- Name: Influenza, Human

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T355

- Name: Acidophilus

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
