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

Chung Shan Medical University

Status: Unknown

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotics fruit vegetable fiber powder product

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04903600

CS2-21043

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotics fruit vegetable fiber powder product

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo