Prevention of Traveler's Diarrhea

NCT06125626 | Completed Phase 2

• 1 other identifier: 153/2023
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean quality of life

  12 weeks

• Incidence of severe diarrhea

  12 weeks

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Dietary Supplement: Probiotical

Placebo

PLACEBO COMPARATOR

This arm will receive a dose of placebo

Other: Placebo

Interventions

Probiotical DIETARY_SUPPLEMENT

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

Probiotics

Placebo OTHER

A daily sachet of placebo will be given to this groups

Placebo

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None predifinied

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Nicola Veronese

Palermo, 90127, Italy

Location

Related 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.

  PMID: 17029137 BACKGROUND

• 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.

  PMID: 9815476 BACKGROUND

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: July 10, 2023
• Primary Completion: October 7, 2023
• Study Completion: October 10, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)