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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04903600

Enrollment

Registered

2021-05-26

Start date

2021-04-22

Completion date

2021-12-31

Last updated

2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DIETARY_SUPPLEMENTProbiotics fruit vegetable fiber powder product

Eat 16 g for once, and twice a day

DIETARY_SUPPLEMENTPlacebo

Eat 16 g for once, and twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Countries

Taiwan

Contacts

Primary ContactChin-Lin Hsu, Professor

clhsu@csmu.edu.tw04-24730022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026