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Prevention of Traveler's Diarrhea

NCT06125626 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-11-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2023-10-07
Completion
2023-10-10

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125626 on ClinicalTrials.gov