Prevention of Traveler's Diarrhea
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Probiotics This arm will receive a daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03 |
Dietary Supplement: Probiotical
A daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03 will be given to this group
|
| Placebo Comparator: Placebo This arm will receive a dose of placebo |
Other: Placebo
A daily sachet of placebo will be given to this groups
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy bikers
-
Able to pass the Amazonia forest by bike
Exclusion Criteria:
- None predifinied
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nicola Veronese | Palermo | Italy | 90127 |
Sponsors and Collaborators
- University of Palermo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Briand V, Buffet P, Genty S, Lacombe K, Godineau N, Salomon J, Vandemelbrouck E, Ralaimazava P, Goujon C, Matheron S, Fontanet A, Bouchaud O. Absence of efficacy of nonviable Lactobacillus acidophilus for the prevention of traveler's diarrhea: a randomized, double-blind, controlled study. Clin Infect Dis. 2006 Nov 1;43(9):1170-5. doi: 10.1086/508178. Epub 2006 Sep 27.
- Hilton E, Kolakowski P, Singer C, Smith M. Efficacy of Lactobacillus GG as a Diarrheal Preventive in Travelers. J Travel Med. 1997 Mar 1;4(1):41-43. doi: 10.1111/j.1708-8305.1997.tb00772.x.
- 153/2023