Prebiotics, Probiotics
Conditions
Keywords
Prebiotics, Probiotics, Microbiota
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.
Interventions
DIETARY_SUPPLEMENTSuper 13 Pro & Prebiotics
Super 13 Pro & Prebiotics was given three times a day for four weeks.
Sponsors
Cheng-Hsin General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Taiwan
Outcome results
None listed