N/A Not Applicable
Conditions
Interventions
Current interventions as of 30/10/2015:
The trial consists of four phases:
1. Pretreatment (4 weeks)
2. First treatment (4 weeks)
3. Washout (4 weeks)
4. Second treatment (4 weeks)
The trial include
(ii) Bb probiotic, constituted by capsules containing at least 1 billion CFU (colony forming units) of freeze-dried Bifidobacterium bifidum Bb. The placebo will be constituted by capsules with identic
Sponsors
DeFENS - Division of Food Microbiology and Bioprocessing (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects, aged between 18 and 55 years 2. Signed study-specific informed consent
Exclusion criteria
Exclusion criteria: 1. Antibiotic therapy during one month before the first visit 2. Viral or bacterial enteritis during the two months before the first visit 3. Gastric or duodenal ulcers during the five years before the first visit 4. Pregnant or breastfeeding women 5. Recent or presumed episodes of alcoholism or drug addiction 6. Presence of conditions determining a non-conformity of the volunteer to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the ability of the probiotic to modify the fecal microbiota in healthy adults (as determined by 16S rRNA gene metagenomic profiling). All outcomes are assessed at V1, V2, V3, and V4. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in bowel habit 2. Change in fecal metabolite concentration (e.g., short chain fatty acids, bile salts) 3. Persistence of probiotic microorganism in the intestine of volunteers All outcomes are assessed at V1, V2, V3, and V4. | — |
Countries
Italy
Outcome results
None listed