Gastrointestinal Function, Intestinal Bacteria Flora
Conditions
Keywords
probiotics, gastrointestinal function, intestinal bacteria flora
Brief summary
The purpose of this study is to evaluate the effect of combined probiotics to improve the gastrointestinal function and intestinal bacteria flora
Detailed description
Probiotics were known to improve gastrointestinal function before. This is a single-blind placebo control clinical study. We will perform gastrointestinal function questionnaire and collect stool as baseline data before the study (0-week). Then healthy subjects will be randomized to two groups. Experimental: probiotics 1 pack bid for 3 weeks. Probiotics : (AB-kefir)：Lactobacillus acidophilus,Bifidobacterium longum,Lactobacillus paracasei,Lactobacillus rhamnosus,Lactobacillus fermentum,Streptococcus thermophilus,Lactobacillus helveticus,Kluyveromyces fragilis. Other components include starch,oligosaccharide,yeast powder, superior standard spice， calcium pantothenate， VitB1， VitB12， biotin and folic acid. Placebo group: placebo 1 pack bid for 3 weeks. Placebo: Except the probiotics (AB-kefir),the other components are the same with study group. Then gastrointestinal function questionnaire and stool collection will be performed at the end of 1st, 2nd, 3rd, and 4th weeks after starting the study.
Interventions
DIETARY_SUPPLEMENTprobiotics
probiotics 1 pack (2g) bid for three weeks
Sponsors
National Science and Technology Council, Taiwan
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy people who are aged between 20 and 40 years
Exclusion criteria
* 1\. People who use probiotics medication and food that can inhibit bacteria growth within one month before the study 2. People who have active infection 3. People who have active or chronic gastro-intestinal disease 4. People who have diarrhea within two weeks before the study 5. People who are drug or alcohol abuser 6. People who are poor compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of gastrointestinal function after probiotics use | 28 days | Changes of gastrointestinal function, such as constipation, abdominal distension and appetite after proiotics and placebo use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of intestinal bacteria flora after probiotics use | 28 days | 1. Changes of intestinal bacteria flora: (1) aerobic bacteria count (2) anaerobic bacteria count (3) Bifidobacterium count (4) Clostridium perfringens count (5) Staphylococcus aureus count (6) E. coli and K. pneumoniae count 2. The ratio for the antibiotics resistant bacteria ( such as Vancomycin-resistant Enterococcus，third-generation cephalosporin resistance E. coli, Methicillin-resistant Staphylococcus aureous, Extended-spectrum beta lactamase E. coli and K. pneumoniae) 3. Changes of the bacteria virulence factors for the intestinal E. coli and K. pneumonia |
Countries
Taiwan
Contacts
Primary ContactMing-Cheng Wang, MD
Backup ContactAn-bang Wu, MD
Outcome results
None listed