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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04903600
• Other study ID #: CS2-21043
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: Chung Shan Medical University
• Contact: Chin-Lin Hsu, Professor
• Phone: 04-24730022
• Email: clhsu[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Probiotics fruit vegetable fiber powder product
Eat 16 g for once, and twice a day
• Placebo
Eat 16 g for once, and twice a day

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung	South

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline serum TNF-a at week 12	Compared the difference of serum cytokine TNF-a level between the week 12 and 0	Week0, Week12
Primary	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
Primary	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