Prevention of Traveler's Diarrhea while Crossing the Amazon Rainforest by Bike with a Supplement Based on Lacticaseibacillus Rhamnosus LR04 (DSM 16605) + Streptococcus Thermophilus FP4 (DSM 18616) + Bifidobacterium Brevis BR03 (DSM 16604): a Phase Two, Randomized, Placebo-controlled, Double-blind, Cross-over Pilot Study
Published |
January 10, 2025 |
Title |
Prevention of Traveler's Diarrhea while Crossing the Amazon Rainforest by Bike with a Supplement Based on Lacticaseibacillus Rhamnosus LR04 (DSM 16605) + Streptococcus Thermophilus FP4 (DSM 18616) + Bifidobacterium Brevis BR03 (DSM 16604): a Phase Two, Randomized, Placebo-controlled, Double-blind, Cross-over Pilot Study |
Authors |
Alberto Vaona, Angela Amoruso, Marco Pane, Nicola Veronese. |
DOI |
10.62684/BYSU4717 |
Keywords |
diarrhoea; probiotics; Amazon forest. |
Downloads |
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Alberto Vaona(a), Angela Amoruso(b), Marco Pane(b), Nicola Veronese(c)
(a) Dipartimento Cure Primarie, Azienda ULSS 9 Scaligera Verona, Italy
(b) Probiotical Research srl, Novara, Italy
(c) Geriatrics Section, Department of Internal Medicine, University of Palermo, Palermo, Italy.
Correspondence to: Nicola Veronese. Geriatric Unit, Department of Medicine, University of Palermo, Palermo 90127, Italy. Electronic address: ilmannato@gmail.com
Abstract
Traveler's diarrhea is a common gastrointestinal illness experienced by individuals traveling to countries with inadequate sanitation and hygiene standards. In this Phase Two, Randomized, Placebo-controlled, Double-blind, Cross-over Pilot Study, we aimed to explore whether a probiotic containing Lacticaseibacillus rhamnosus LR04 (DSM 16605) + Streptococcus thermophilus FP4 (DSM 18616) + Bifidobacterium breve BR03 (DSM 16604) could prevent traveler’s diarrhea and improve quality of life over three months of follow-up in a cohort of athletes biking though the Amazon rainforest. In this pilot study including 3 cyclists randomly assigned to one of the two experimental groups (one probiotic, one placebo). The three participants were men aged 47, 63, 64 years. During the follow-up period, we observed one episode of diarrhea in the probiotic group and one in placebo (p=1.00). However, the number of days with diarrhea was only two in the active group and seven in the placebo group (p=0.33). No episodes of severe diarrhea were observed during the follow-up. At the end of the study, the active group showed a higher quality of life, but no statistically significant. In conclusion, our study suggests that the supplementation with Lacticaseibacillus rhamnosus LR04 (DSM 16605) + Streptococcus thermophilus FP4 (DSM 18616) + Bifidobacterium breve BR03 (DSM 16604) may help prevent traveler’s diarrhea in extreme conditions such as to biking through the Amazon rainforest. However, future larger studies involving a more general population are needed to confirm our findings.
Declarations
Acknowledgments
We thank Margherita Patrucco for her revision.
Conflict of Interest
The Authors declare that there is no conflict of interest.
Funding
The authors have no funding sources to report.
Author Contributions
Vaona: data collection; Veronese: data analysis; Amoruso, Pane: critical revision of the paper. All authors approved the final version of the manuscript submitted.
References
- Leung AK, Leung AA, Wong AH, Hon KL. Travelers’ diarrhea: a clinical review. Recent patents on inflammation & allergy drug discovery. 2019;13(1):38-48.
- Diemert DJ. Prevention and self-treatment of traveler's diarrhea. Clinical microbiology reviews. 2006;19(3):583-94.
- McFarland LV. Meta-analysis of probiotics for the prevention of traveler's diarrhea. Travel medicine and infectious disease. 2007;5(2):97-105.
- Briand V, Buffet P, Genty S, Lacombe K, Godineau N, Salomon J, et al. Absence of efficacy of nonviable Lactobacillus acidophilus for the prevention of traveler's diarrhea: a randomized, double-blind, controlled study. Clinical infectious diseases. 2006;43(9):1170-5.
- Devereaux P, Manns BJ, Ghali WA, Quan H, Guyatt GH. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Controlled clinical trials. 2002;23(4):380-8.
- Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scandinavian journal of gastroenterology. 1997;32(9):920-4.
- Jakobsson U. Using the 12-item Short Form health survey (SF-12) to measure quality of life among older people. Aging clinical and experimental research. 2007;19:457-64.
- Steffen R, Gyr K. Diet in the treatment of diarrhea: from tradition to evidence. Clinical Infectious Diseases. 2004;39(4):472-3.