ProbioticsNCT04043000
Super 13 Pro & Prebiotics on the Human Intestinal Microflora
A study testing Super 13 Pro & Prebiotics in people with Probiotics and Prebiotics, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotics, Prebiotics
- What is being tested?
- Super 13 Pro & Prebiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Oct 2019to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers and willing to give voluntary written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Probiotics, Prebiotics
- Being tested
- Super 13 Pro & Prebiotics
- Keywords
- Prebiotics, Probiotics, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super 13 Pro & PrebioticsDietary supplement
"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Super 13 Pro & Prebiotics | Experimental | "Super 13 Pro \& Prebiotics" was given three times a day for four weeks. Receives: Dietary Supplement: Super 13 Pro & Prebiotics |
| Placebo | Placebo comparator | " The placebo without Super 13 Pro \& Prebiotics" was given three times a day for four weeks. Receives: Dietary Supplement: Super 13 Pro & Prebiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2nd, and 4th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start21 Oct 2019
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YI-HSIEN LIN, Principal investigator, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043000
- Sponsor's protocol ID
- Super13-2019
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2019
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Super 13 Pro & Prebiotics on the Human Intestinal Microflora: a Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04043000
- Acronym / sponsor ID
- Super13-2019
- Conditions
- Probiotics, Prebiotics
- Keywords
- Prebiotics, Probiotics, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Super 13 Pro & Prebiotics | Experimental | Dietary Supplement: Super 13 Pro & Prebiotics"Super 13 Pro \& Prebiotics" was given three times a day for four weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Super 13 Pro & Prebiotics" The placebo without Super 13 Pro \& Prebiotics" was given three times a day for four weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult volunteers and willing to give voluntary written informed consent
Key exclusion criteria (7 listed)
- Major systemic disease
- Pregnancy, parturient and feeding woman, or expect to be pregnant
- Abnormal liver function
- Abnormal renal function
- Abnormal gastrointestinal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super 13 Pro & Prebiotics"Super 13 Pro \& Prebiotics" was given three times a day for four weeks. | Dietary supplement | Placebo, Super 13 Pro & Prebiotics |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YI-HSIEN LIN principal investigator
Cheng-Hsin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super 13 Pro & Prebiotics in people with Probiotics and Prebiotics, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal Microflora: Bifidobacterium spp. (time frame: 2nd, and 4th weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.