Super 13 Pro & Prebiotics on the Human Intestinal Microflora

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-21

Study Completion Date

2019-11-18

Brief Summary

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This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro \& Prebiotics" or the control article, "The placebo without Super 13 Pro \& Prebiotics" during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.

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Detailed Description

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This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro \& Prebiotics" or the control article, "The placebo without Super 13 Pro \& Prebiotics" three times a day during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.

Conditions

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Probiotics Prebiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study aim to investigate the roles of the test article in improving gastrointestinal functions and gut microbiota of humans. A total 40 healthy adults were recruited and randomly divided into experimental and control groups, with 20 subjects each, for a 4-week trial. The subjects took the test article, "Super 13 Pro \& Prebiotics" or the control article, "The placebo without Super 13 Pro \& Prebiotics" during the 4-week drug-intake period. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts of Bifidobacterium spp., Clostridium perfringens, Lactobacillus spp., and Coliform.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The subjects took the test article, "Super 13 Pro \& Prebiotics" or the control article, "The placebo without Super 13 Pro \& Prebiotics" during the 4-week drug-intake period.

Study Groups

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Super 13 Pro & Prebiotics

"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

Group Type EXPERIMENTAL

Super 13 Pro & Prebiotics

Intervention Type DIETARY_SUPPLEMENT

"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

Placebo

" The placebo without Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

Group Type PLACEBO_COMPARATOR

Super 13 Pro & Prebiotics

Intervention Type DIETARY_SUPPLEMENT

"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

Interventions

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Super 13 Pro & Prebiotics

"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy adult volunteers and willing to give voluntary written informed consent

Exclusion Criteria

* Major systemic disease
* Pregnancy, parturient and feeding woman, or expect to be pregnant
* Abnormal liver function
* Abnormal renal function
* Abnormal gastrointestinal function
* Take medications for gastrointestinal and metabolic diseases
* Occurrences of severe diseases within 6 months, such as stroke, myocardial infarction, major trauma and surgery • Poor compliance for study protocol

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes