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

Not Applicable

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotics fruit vegetable fiber powder product

• Registration Number: NCT04903600
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2021-04-22
• Study First Submitted: 2021-05-23
• Study First Submitted QC: 2021-05-23
• Study First Posted: 2021-05-26
• Status Verified: 2021-09
• Primary Completion: 2021-09
• Last Update Submitted: 2021-09-12
• Last Update Posted: 2021-09-14
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	32g placebo contained only maltodextrin (100%) for 12 weeks
Probiotics	Probiotics fruit vegetable fiber powder product	32g probiotics fruit vegetable fiber powder product contained 1.12\*10(11) CFU of probiotics for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline serum IL-6 at week 12	Week0, Week12	Compared the difference of serum IL-6 level between the week 12 and 0
Change from baseline serum IL-10 at week 12	Week0, Week12	Compared the difference of serum IL-10 level between the week 12 and 0
Change from baseline serum TNF-α at week 12	Week0, Week12	Compared the difference of serum cytokine TNF-α level between the week 12 and 0

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, South, Taiwan