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

NCT ID: NCT04903600

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Probiotics

32g probiotics fruit vegetable fiber powder product contained 1.12\*10(11) CFU of probiotics for 12 weeks

Group Type EXPERIMENTAL

Probiotics fruit vegetable fiber powder product

Intervention Type DIETARY_SUPPLEMENT

Eat 16 g for once, and twice a day

Placebo

32g placebo contained only maltodextrin (100%) for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eat 16 g for once, and twice a day

Interventions

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Probiotics fruit vegetable fiber powder product

Eat 16 g for once, and twice a day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Eat 16 g for once, and twice a day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Probiotics

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TCI Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chin-Lin Hsu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Jou Chien, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Ying-Chi Chen, MS Student

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, South, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin-Lin Hsu, Professor

Role: CONTACT

04-24730022 ext. 12222

Facility Contacts

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Chin-Lin Hsu, Professor

Role: primary

04-24730022 ext. 12222

Other Identifiers

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CS2-21043

Identifier Type: -

Identifier Source: org_study_id

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