Super 13 Pro & Prebiotics on the Human Intestinal Microflora

Study Overview
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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.

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.

Official Title
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Effects of Super 13 Pro & Prebiotics on the Human Intestinal Microflora: a Double-blind, Randomized, Placebo-controlled Study

Conditions
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Probiotics, Prebiotics

Intervention / Treatment
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* Dietary Supplement: Super 13 Pro & Prebiotics


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Super 13 Pro & Prebiotics<br>Super 13 Pro & Prebiotics was given three times a day for four weeks. | Dietary Supplement: Super 13 Pro & Prebiotics<br>* Super 13 Pro & Prebiotics was given three times a day for four weeks.<br>|
| Placebo Comparator: Placebo<br> The placebo without Super 13 Pro & Prebiotics was given three times a day for four weeks. | Dietary Supplement: Super 13 Pro & Prebiotics<br>* Super 13 Pro & Prebiotics was given three times a day for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Microflora: Bifidobacterium spp. | Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts. | 2nd, and 4th weeks | 
| Intestinal Microflora: Clostridium perfringens | Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts. | 2nd, and 4th weeks | 
| Intestinal Microflora: Lactobacillus spp. | Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts. | 2nd, and 4th weeks | 
| Intestinal Microflora: Coliform | Change from baseline bacterial counts at 2nd, and 4th weeks. Fecal specimens were collected at the 0th, 2nd, and 4th weeks of the trial for analyzing the bacterial counts. | 2nd, and 4th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prebiotics, Probiotics, Microbiota