Prevention of Traveler's Diarrhea

NCT ID: NCT06125626

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2023-10-10

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.

Conditions

Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotics

This arm will receive a daily sachet of Lacticaseibacillus rhamnosus LR04 + Streptococcus thermophilus FP4 + Bifidobacterium breve BR03

Group Type: EXPERIMENTAL

Probiotical

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

This arm will receive a dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A daily sachet of placebo will be given to this groups

Interventions

Probiotical

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A daily sachet of placebo will be given to this groups

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy bikers
• Able to pass the Amazonia forest by bike

Exclusion Criteria

• None predifinied

• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Nicola Veronese

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nicola Veronese

Palermo, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 17029137 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9815476 (View on PubMed)

Other Identifiers

153/2023

Identifier Type: -

Identifier Source: org_study_id