- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043000
Super 13 Pro & Prebiotics on the Human Intestinal Microflora
July 8, 2020 updated by: Cheng-Hsin General Hospital
Effects of Super 13 Pro & Prebiotics on the Human Intestinal Microflora: a Double-blind, Randomized, Placebo-controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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" 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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taipei City
-
Taipei, Taipei City, Taiwan, 112
- Cheng Hsin General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Super 13 Pro & Prebiotics
"Super 13 Pro & Prebiotics" was given three times a day for four weeks.
|
"Super 13 Pro & Prebiotics" was given three times a day for four weeks.
|
Placebo Comparator: Placebo
" The placebo without Super 13 Pro & Prebiotics" was given three times a day for four weeks.
|
"Super 13 Pro & Prebiotics" was given three times a day for four weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intestinal Microflora: Bifidobacterium spp.
Time Frame: 2nd, and 4th weeks
|
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
Time Frame: 2nd, and 4th weeks
|
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.
Time Frame: 2nd, and 4th weeks
|
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
Time Frame: 2nd, and 4th weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: YI-HSIEN LIN, Cheng-Hsin general hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 21, 2019
Primary Completion (Actual)
November 18, 2019
Study Completion (Actual)
November 18, 2019
Study Registration Dates
First Submitted
July 10, 2019
First Submitted That Met QC Criteria
August 1, 2019
First Posted (Actual)
August 2, 2019
Study Record Updates
Last Update Posted (Actual)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Super13-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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