Super 13 Pro & Prebiotics on the Human Intestinal Microflora

Not Applicable

Completed

• Conditions: Prebiotics; Probiotics
• Interventions: Dietary Supplement: Super 13 Pro & Prebiotics

• Registration Number: NCT04043000
• Lead Sponsor: Cheng-Hsin General Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-02
• Study Start: 2019-10-21
• Primary Completion: 2019-11-18
• Study Completion: 2019-11-18
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Super 13 Pro & Prebiotics	Super 13 Pro & Prebiotics	"Super 13 Pro \& Prebiotics" was given three times a day for four weeks.
Placebo	Super 13 Pro & Prebiotics	" The placebo without Super 13 Pro \& Prebiotics" was given three times a day for four weeks.

Primary Outcome Measures

Name	Time	Method
Intestinal Microflora: Lactobacillus spp.	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	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: Bifidobacterium spp.	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	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.

Trial Locations

Locations (1)

Cheng Hsin General Hospital; 🇨🇳 Taipei, Taipei City, Taiwan