Super 13 Pro & Prebiotics on the Human Intestinal Microflora

Probiotics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043000
• Other study ID #: Super13-2019
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Prebiotics
• Probiotics

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