Efficacy Assessment of Probiotics Product on Intestinal Health and Immune System Improvement

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of probiotics product (probiotics fruit vegetable fiber powder) on intestinal health and immune system improvement in adults

Detailed Description
-----------------
This 12 weeks randomized, single-blind and placebo-controlled study will be conduct in fifty adults. Subjects will be recruited and assigned into two groups in a 1:1 ratio (placebo, n = 25; probiotics, n=25). During the 12 weeks intervention, the subjects should take 32 g powder of placebo or probiotics product (eat 16 g for once, and twice a day). The two powder supplied in an aluminum sachet, and all products were identical in taste. Subjects also should complete the assessment of anthropometric measurement, health conditions, food record, and sample collection (feces and blood) at week 0, 4, 8 and week 12.

Official Title
-----------------
Efficacy Assessment of Probiotics Fruit Vegetable Fiber Powder on Intestinal Health and Immune System Improvement in Human Trial

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotics fruit vegetable fiber powder product
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria include male or female participants to be aged 20-60 years old, who had colds more than four times in the past year or had gastric Infection by Helicobacter pylori or peptic ulcer, body mass index within a healthy range (18.5-27 kg/m2) and willing to commit throughout the experiment. Exclusion Criteria: Exclusion criteria included cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity, have systemic infections, use probiotics, prebiotics, fruit vegetable fiber supplementation, and lactose Intolerance or cow's milk allergic. Individuals who, in opinion of the investigator, seemed unlikely to complete the trial were also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>32g probiotics fruit vegetable fiber powder product contained 1.12*10(11) CFU of probiotics for 12 weeks | Dietary Supplement: Probiotics fruit vegetable fiber powder product<br>* Eat 16 g for once, and twice a day<br>* Other names: Probiotics;|
| Placebo Comparator: Placebo<br>32g placebo contained only maltodextrin (100%) for 12 weeks | Dietary Supplement: Placebo<br>* Eat 16 g for once, and twice a day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline serum TNF-α at week 12 | Compared the difference of serum cytokine TNF-α level between the week 12 and 0 | Week0, Week12 | 
| Change from baseline serum IL-6 at week 12 | Compared the difference of serum IL-6 level between the week 12 and 0 | Week0, Week12 | 
| Change from baseline serum IL-10 at week 12 | Compared the difference of serum IL-10 level between the week 12 and 0 | Week0, Week12 |