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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04043000
Other study ID # Super13-2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2019
Est. completion date November 18, 2019

Study information

Verified date July 2020
Source Cheng-Hsin General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 18, 2019
Est. primary completion date November 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Cheng Hsin General Hospital Taipei Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Cheng-Hsin General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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