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OpenTrials
Completed

NCT Number: NCT06125626

Prevention of Traveler's Diarrhea

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.

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Nicola Veronese

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None predifinied

Treatment and study plan

Probiotical

Dietary Supplement

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

Placebo

Other

A daily sachet of placebo will be given to this groups

Primary outcomes

  1. Incidence of diarrhea

    Time frame: 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 outcomes

  1. Mean quality of life

    Time frame: 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.

  2. Incidence of severe diarrhea

    Time frame: 12 weeks

    Severe diarrhea will be defined as a diarrhea requiring hospitalization or intravenous hydratation

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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