Effect of the probiotic strain BB-12® on the gastrointestinal function of healthy adults
- Conditions
- ow defecation frequency and abdominal discomfortDigestive SystemLow defecation frequency and abdominal discomfort
- Registration Number
- ISRCTN18128385
- Lead Sponsor
- Chr. Hansen A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1740
1. Healthy
2. Age 18–70 years
3. Body-mass index 19–35 kg/m2
4. General abdominal discomfort or complaints
5. A low defecation frequency
1. History of hypersensitivity to any of the ingredients of the study products
2. History of lactose intolerance
3. History or diagnosis of gastrointestinal disease, irritable bowel syndrome or complicated gastrointestinal surgery
4. Depressive disorder
5. Any physical abnormality or medical condition that could have an effect on gastrointestinal discomfort
6. Participation in any other clinical study
7. Not willing or able to provide written informed consent for participation in the study or for transmission of personal pseudonymised data
8. Women not willing or able to use a reliable contraceptive method
9. Pregnancy
10. Lactation
11. Wish to become pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Stool frequency will be measured with a completed Bristol Stool Form at baseline and each week during the intervention period<br>2. General abdominal discomfort will be measured each week during the intervention period by subject’s rating of general abdominal discomfort compared with before the study (markedly relieved, somewhat relieved, unchanged, somewhat worsened and markedly worsened)
- Secondary Outcome Measures
Name Time Method Abdominal discomfort symptoms will be rated daily during the entire study with a Likert scale (0=no, 1=mild, 2=moderate, 3=severe and 4=unbearable) and results averaged for baseline and each week during the intervention period