Clinical trial NCT04043000: Super 13 Pro & Prebiotics on the Human Intestinal Microflora
Official title: Effects of Super 13 Pro & Prebiotics on the Human Intestinal Microflora: a Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Probiotics
Prebiotics
Keywords: Prebiotics
Probiotics
Microbiota
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intestinal Microflora: Bifidobacterium spp.
timeFrame: 2nd, and 4th weeks
measure: Intestinal Microflora: Clostridium perfringens
timeFrame: 2nd, and 4th weeks
measure: Intestinal Microflora: Lactobacillus spp.
timeFrame: 2nd, and 4th weeks
measure: Intestinal Microflora: Coliform
timeFrame: 2nd, and 4th weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
state: Taipei City
Study officials:
affiliation: Cheng-Hsin General Hospital
name: YI-HSIEN LIN
role: PRINCIPAL_INVESTIGATOR
References: