Diarrhea
Conditions
Brief summary
The prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). The very attractive prospect of preventing travellers' diarrhea without systemic antibiotics has fueled interest in probiotics for this purpose. However, not all probiotics are identical, and the results of studies conducted with a particular agent cannot be generalized to indicate that any probiotic agent would be successful in the same clinical situation. Probiotics such as Lactobacillus GG have been shown to reduce the incidence of diarrhea in travelers in randomized controlled trials. In contrast, another Lactobacillus preparation, non-viable Lactobacillus acidophilus, showed no benefit over placebo in a randomized, double-blind, controlled trial of 174 travelers. The reasons for this are unclear, but could be related to the fact that the bacteria were not viable or a peculiarity of the strain selected for testing.
Interventions
DIETARY_SUPPLEMENTProbiotical
A daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03 will be given to this group
OTHERPlacebo
A daily sachet of placebo will be given to this groups
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
* Healthy bikers * Able to pass the Amazonia forest by bike
Exclusion criteria
* None predifinied
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of diarrhea | 12 weeks | Diarrhea will be defined using the Bristol's scale (value of 7) in a scale between 1 and 7, higher values reflecting more diarrhoic attitude |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean quality of life | 12 weeks | Quality of life will be assessed using the short-form 12 (SF-12) with a standardized score between 0 and 100% compared to the Italian population. |
| Incidence of severe diarrhea | 12 weeks | Severe diarrhea will be defined as a diarrhea requiring hospitalization or intravenous hydratation |
Countries
Italy
Outcome results
None listed