Prevention of Traveler's Diarrhea

Diarrhea Clinical Trial

Official title:

Prevention of Traveler's Diarrhea While Crossing the Amazon Forest by Bike With a Supplement Based on Lacticaseibacillus Rhamnosus LR04 + Streptococcus Thermophilus FP4 + Bifidobacterium Brevis BR03: a Phase Two, Randomized, Placebo-controlled, Double-blind, Cross-over Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06125626
• Other study ID #: 153/2023
• Status: Completed
• Phase: Phase 2
• Start date: July 10, 2023
• Est. completion date: October 10, 2023

Study information

• Verified date: November 2023
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 10, 2023
• Est. primary completion date: October 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy bikers

• Able to pass the Amazonia forest by bike

Exclusion Criteria:

• None predifinied

Related Conditions & MeSH terms

• Diarrhea

Intervention

Dietary Supplement:
• Probiotical
A daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03 will be given to this group

Other:
• Placebo
A daily sachet of placebo will be given to this groups

Locations

Country	Name	City	State
Italy	Nicola Veronese	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of diarrhea	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	12 weeks
Secondary	Mean quality of life	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.	12 weeks
Secondary	Incidence of severe diarrhea	Severe diarrhea will be defined as a diarrhea requiring hospitalization or intravenous hydratation	12 weeks