Super 13 Pro & Prebiotics on the Human Intestinal Microflora

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: Probiotics; Prebiotics
• Intervention / Treatment: Dietary supplement: Super 13 Pro & Prebiotics

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

Study Locations

• Taiwan
  • Taipei City
    • Taipei, Taipei City, Taiwan, 112
      • Cheng Hsin General Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

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.	Dietary supplement: Super 13 Pro & Prebiotics; "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.	Dietary supplement: Super 13 Pro & Prebiotics; "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.	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

Collaborators and Investigators

• Sponsor: Cheng-Hsin General Hospital
• Investigators: Principal Investigator: YI-HSIEN LIN, Cheng-Hsin general hospital

Study record dates

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: Microbiota; Probiotics; Prebiotics
• 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